2bbrands.com/drugstore 09-Sep-03

Public Health Service Food and Drug Administration
	Rockville, MD 20857

Via Express Mail/Return Receipt

& Faxed to (775) 924-4501

Warning Letter

September 9, 2003

Mr. David Anderson

Registrant

2bbrands.com/drugstore

P.O. Box 3567

San Francisco, CA 90266

Dear Mr. Anderson:

The Food and Drug Administration (FDA) has learned that, through the websites www.2bbrands.com and ww.mexican-drugstore.com, you are selling “Accutane topical gel” to United States (U.S.) consumers. Accutane is the trade name for a prescription drug approved for marketing in the United States under an approved new drug qdication submitted by RochePharmaceuticals. Nutley, New Jersey. The only approved Accutane products approved for marketing in the United States are capsules for oral ingestion. Even though the the mexican-drugstore.com order form states that the product offered for sale is Accutane topical gel,” the label of the actual product shipped states that it is “ISOTEX ISOTRENINOINA GEL 0.05%. The labeling for this product is in Spanish. Neither “Accutane topical gel” nor “Isotrex” has an approved new drug application, and they may not be legally marketed in the United States.

You sell “Accutane topical gel" without a prescription to the American consumers from a Mexican pharmacy. As discussed in greater detail below, these actions violate the Federal Food, Drug and Cosmetic Act (FD & C Act or Act), 21 United States Code

(U.S.C.) 301 Et seq.

When a U.S. resident logs onto the Internet site, www.2bbrands.com/drugstore they are automatically taken to that states in part, “***US Corporation enables you to purchase medicines from Mexico***Privately delivered to your address Medicines in Mexico are made from the same quality ingredients, made by the same companies *** in compliance with all U.S. and international laws*** ” Your firm packages the dispensed prescription and mails it directly to the resident in the United States.

The “Accutane” product sold through your web site is labeled in part, “ISOTREX ***ISOTRETlNOINA GEL 0.05 %***Tuba con 30 g Formila: Cada 100 g contiene: Isotretinoina 0.05g Excipiente c.b.p. 100 g. ***Hecho en Mexico por STIEFEL MEXICANA, S.A. DE C.V., Eje Norte Sur. No. 11, Nuevo Parques Industrial, San Juan del Rio Qro., C.P. 76809. Segun Formula y bajo licencia de: STIEFEL LABORATORIES. INC.,. Coral Gables, FL 33134 ***Late. 130002F428 CAD. 15/JUN/2004***.”

Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part.

“Accutane must not be used by females who me pregnant...must be prescribed under the System to manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,“ (meaning special training has been given to the prescribin, tr licensed practitioner and the patient) “and no telephone or computerized prescriptions are permitted. ” The approved Accutane is for oral ingestion. FDA has not approved a topical gel version of Accutane or any other isotretinoin drug.

Because it has serious risks, isotrctinoin is available in the U.S. only under specially created safety controls. These safety controls are bypassed wbcn this drug is purchased from foreign sources or over the Internet, placing patients wvho use this imported drug at higher risk.

The isotretinoin dispensed through mexcian-drugstore.com is a "new drug” as defined by section 201(p) of the Act. Under Section 505(a) of the Act, a “new drug” may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug, The continued distribution of this product into the U.S. withoul an approved NDA is a prohibited act as set forth in Section 301 (d) of the Act.

The isotretinoin dispensed through mexican-drugstore.com is also misbranded under section 502(f)(1) of the Act because its labeling fails to bear adequate directions for the uses for which it is being offered and it is not exempt from this requirement (See 21 CFR 201.115). The drug is also not allowed to bear the required informarion solely in Spanish because it is not distributed solely in the commonwealth of Puerto Rico or in a U.S. Territory where the predominant language is Spanish (See 21 CFR 201.15(c)).

This drug is also misbranded pursuant to section 503(b)(1) of the Act because it is dispensed without a prescription.



In addition, faisc promotional statements are being made by you on www.2bbrands.com and www.mexican-drug.store.com, such as, “All items arc shipped *** in compliance with all U.S. and international laws.” You are giving the incotrect impression that all the drugs sold on your website are approved and/or legal to be sold and shipped to U.S. residents. This is a false and misleading statement on your Internet site causing the drugs you distribute to be misbranded pursuant to section 502(a) of the Act.

This letter is not intended to identify all of the ways in which your activities might be in violation of United States Iaw. For example, in addition to isotretinoin, your pharmacy also offers for sale and shipment to U.S. consumers numerous other prescription drugs.

FDA believes that virtually ail shipments of prescription drugs imported from non-U.S. pharmacies will violate the Act. It is your responsibility to ensure that all drug products dispensed and distributed by you and your website into the United States are in

compliance with applicable legal requirements.

The agency has taken steps to warn our residents that drugs sold via the Internet, from foreign sources, may not be approved for marketing in this country, and may not be legally imported. With copies of this Ietter, we are advising Mexican, New York, and

California drug regulatory officials of these potential violations, In addition, we are advising the U.S. CustomÂ’s Bureau, through an Import Alert, that shipments offered for importation into the U.S. as a result of your activities may bc detained and subject to

refusal of entry.

You are instructed to cease these practices, and you are requestcd within fifteen (15) days of your receipt of this letter, to describe the actions you are taking to assure that your operations are in full compliance with United States law. Please address your

correspondence to Mr. Melvin F. Szymanski. Compliance Officer, at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance. HFD-310, 5600 Fishers Lane, Rockville, MD 20857.

You should be aware that violations of the FD&C Act could result in seizure, injunction, and/or prosecution without further notice.

 

Sincerely,

/s/

David J. Horowitz, Esq.

Director

Office of Compliance

Center for Drug Evaluation and Research

 

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2bBrands 09-Sep-03

Public Health Service Food and Drug Administration
	Rockville, MD 20857

Via Express Mail/Return Receipt
& Faxed to (775) 924-4501

Warning Letter

September 9, 2003

Mr. David Anderson
Registrant
2bbrands
P.O. Box 0798
Manhattan Beach, CA 90266

Dear Mr. Anderson:

The Food and Drug Administration (FDA) has learned that, through the websiteswww.2bbrands.com and ww.mexican-drugstore.com, you are selling “Accutanetopical gel” to United States (U.S.) consumers. Accutane is the trade namefor a prescription drug approved for marketing in the United States under anapproved new drug qdication submitted by Roche Pharmaceuticals. Nutley, MewJersey. The only approved Accutane products approved for marketing in the UnitedStates are capsules for oral ingestion. Even though the the mexican-drugstore.comorder form states that the product offered for sale is Accutane topical gel,”the label of the actual product shipped states that it is “ISOTEX ISOTRENINOINAGEL 0.05%. The labeling for this product is in Spanish. Neither “Accutanetopical gel” nor “Isotrex” has an approved new drug application,and they may not be legally marketed in the United States.

You sell “Accutane topical gel" without a prescription to the Americanconsumers from a Mexican pharmacy. As discussed in greater detail below, theseactions violate the Federal Food, Drug and Cosmetic Act (FD & C Act or Act),21 United States Code
(U.S.C.) 301 Et seq.

When a U.S. resident logs onto the Internet site, www.2bbrands.com/drugstorethey are automatically taken to that states in part, “***US Corporationenables you to purchase medicines from Mexico***Privately delivered to youraddress Medicines in Mexico are made from the same quality ingredients, madeby the same companies *** in compliance with all U.S. and international laws***” Your firm packages the dispensed prescription and mails it directly tothe resident in the United States.

The “Accutane” product sold through your web site is labeled in part,“ISOTREX ***ISOTRETlNOINA GEL 0.05 %***Tuba con 30 g Formila: Cada 100g contiene: Isotretinoina 0.05g Excipiente c.b.p. 100 g. ***Hecho en Mexicopor STIEFEL MEXICANA, S.A. DE C.V., Eje Norte Sur. No. 11, Nuevo Parques Industrial,San Juan del Rio Qro., C.P. 76809. Segun Formula y bajo licencia de: STIEFELLABORATORIES. INC.,. Coral Gables, FL 33134 ***Late. 130002F428 CAD. 15/JUN/2004***.”

Accutane (isotretinoin) is a systemically administered retinoid approved in1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significantpotential risks, including that it may cause severe birth defects. The approvedAccutane labeling states in part.
“Accutane must not be used by females who me pregnant...must be prescribedunder the System to manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellowAccutane Qualification Sticker must be on each prescription,“ (meaningspecial training has been given to the prescribin, tr licensed practitionerand the patient) “and no telephone or computerized prescriptions are permitted.” The approved Accutane is for oral ingestion. FDA has not approved a topicalgel version of Accutane or any other isotretinoin drug.

Because it has serious risks, isotrctinoin is available in the U.S. only underspecially created safety controls. These safety controls are bypassed wbcn thisdrug is purchased from foreign sources or over the Internet, placing patientswvho use this imported drug at higher risk.

The isotretinoin dispensed through mexcian-drugstore.com is a "new drug”as defined by section 201(p) of the Act. Under Section 505(a) of the Act, a“new drug” may not be introduced or delivered for introduction intointerstate commerce unless an FDA-approved new drug application (NDA) is ineffect for such drug, The continued distribution of this product into the U.S.withoul an approved NDA is a prohibited act as set forth in Section 301(d) ofthe Act.

The isotretinoin dispensed through mexican-drugstore.com is also misbrandedunder section 502(f)(1) of the Act because its labeling fails to bear adequatedirections for the uses for which it is being offered and it is not exempt fromthis requirement (See 21 CFR 201.115). The drug is also not allowed to bearthe required informarion solely in Spanish because it is not distributed solelyin the commonwealth of Puerto Rico or in a U.S. Territory where the predominantlanguage is Spanish (See 21 CFR 201.15(c)).

This drug is also misbranded pursuant to section 503(b)(1) of the Act becauseit is dispensed without a prescription.

In addition, faisc promotional statements are being made by you on www.2bbrands.comand www.mexican-drug.store.com, such as, “All items arc shipped *** incompliance with all U.S. and international laws.” You are giving the incotrectimpression that all the drugs sold on your website are approved and/or legalto be sold and shipped to U.S. residents. This is a false and misleading statementon your Internet site causing the drugs you distribute to be misbranded pursuantto section 502(a) of the Act.

This letter is not intended to identify all of the ways in which your activitiesmight be in violation of United States Iaw. For example, in addition to isotretinoin,your pharmacy also offers for sale and shipment to U.S. consumers numerous otherprescription drugs.
FDA believes that virtually ail shipments of prescription drugs imported fromnon-U.S. pharmacies will violate the Act. It is your responsibility to ensurethat all drug products dispensed and distributed by you and your website intothe United States are in
compliance with applicable legal requirements.

The agency has taken steps to warn our residents that drugs sold via the Internet,from foreign sources, may not be approved for marketing in this country, andmay not be legally imported. With copies of this Ietter, we are advising Mexican,New York, and
California drug regulatory officials of these potential violations, In addition,we are advising the U.S. Custom’s Bureau, through an Import Alert, thatshipments offered for importation into the U.S. as a result of your activitiesmay bc detained and subject to
refusal of entry.

You are instructed to cease these practices, and you are requestcd within fifteen(15) days of your receipt of this letter, to describe the actions you are takingto assure that your operations are in full compliance with United States law.Please address your
correspondence to Mr. Melvin F. Szymanski. Compliance Officer, at the U.S. Foodand Drug Administration, Center for Drug Evaluation and Research, Office ofCompliance. HFD-310, 5600 Fishers Lane, Rockville, MD 20857.

You should be aware that violations of the FD&C Act could result in seizure,injunction, and/or prosecution without further notice.

 

Sincerely,

/s/

David J. Horowitz, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research

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1 Coral Calcium/Thin America 10-Jun-03

Departmentof Health and Human Services	Public Health Service Food and Drug Administration
	5100 Paint Branch Parkway College Park, MD 20740

JUN 10 2003

WARNING LETTER

VIA OVERNIGHT DELIVERY

I Coral Calcium/Thin America
44290 Delco Blvd
Sterling Heights, MI 48310
33184 Ryan Road
Sterling Heights, MI 48310

Dear Sir or Madam:

The Food and Drug Administration (FDA) has reviewed your web site at the following address: www. l-coral-calcium.com. This review shows serious violations of the Federal Food, Drug, and Cosmetio.Act (the Act) in the labeling of your Coral Calcium products. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment orprevention of disease in man are drugs [Section 201(g)(1)(B) of the Act]. Your web site claims that your products are useful in the prevention, treatment, or mitigation of numerous serious diseases. The labeling of your products bears the following claims:

• "Defy arthritis. . .
•"Combat arthritic conditions and heart disease"
•". . .helping to prevent the risk of degenerative diseases . . . "
•"Helps . . . high cholesterol . . . rheumatoid arthritis, ulcers, psoriasis, ulcerative colitis,gastroenteritis . . . "

These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act.Because the products are not generally recognized as safe and effective when used as labeled,they are also new drugs as defined in section 201(p) of the Act. Under section 505 of the Act,a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These drugs are also misbranded within the meaning of section 502(f)(l) of the Act, in that the labeling for these drugs fails to bear adequate directions for use.

Even if the labeling for these products did not contain language that caused them to be drugsand the products met the definition of a dietary supplement, they would violate otherprovisions of the Act. Under the Act, labeling for a dietary supplement may include claimsabout the product's effect on the structure or function of the human body. However, these"structure/function" claims must be truthful and not misleading. Claims that lacksubstantiation cause a product to be misbranded under sections 403(a)(1) and 403(r)(6) of theAct.

The labeling of your products bears structure/function claims that include the following :

•"Cleanse the kidneys, intestines, and liver"
• "Achieve a healthy alkaline level"
•"Breakdown heavy metals and drug residues in your body"
•"Coral Calcium . . .keeps the pH level of our body fluids in sync . . . "
•"Coral Calcium raises the alkalinity of the extra cellular fluid that surrounds your cells."

We have reviewed these claims and have concluded that they are not supported by reliablescientific evidence. Because these claims lack substantiation, they cause your products to bemisbranded within the meaning of sections 403(a)(l) and 403(r)(6)(B) of the Act,

The above violations are not meant to be an all-inclusive list of deficiencies in your productsand their labeling. It is your responsibility to ensure that products marketed by your firmcomply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers anddistributors of those products. You should take prompt action to correct these, deviations andprevent their future recurrence. Failure to do so may result in enforcement action withoutfurther notice.

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps' you have taken to correct the violations noted above and toassure that similar violations do not occur. If corrective actions cannot be completed withinfifteen working days, state the reason for the delay and the time within which the correctionswill be completed.

Your reply should be addressed to Compliance Officer Jennifer Thomas at the above address.

Sincerely,

/S/

Joseph R. Baca
Director
Office of Compliance
Center for Food Safety and
Applied Nutrition

 

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A Spicy World Company 18-Mar-03

Departmentof Health and Human Services            PublicHealth Service

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Food and Drug Administration
New Orleans District
Southeast Region
6600 Plaza Drive Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520

March 18, 2003

WARNING LETTER NO. 2003-NOL-12

FEDERAL EXPRESS

Overnight Delivery

Mr. Ghulam H. Ansary, President and Owner

A Spicy World Company

2423 Bainbridge, Suite 200

Kenner, Louisiana 70065

Dear Mr. Ansary:

The U.S. Food and Drug Administration (FDA) inspected your spice processing and associated food storage warehouse facility, located at 2423 Bainbridge, Suite 200, Kenner, Louisiana, during January 21, 22, and 28, 2003. The inspection was conducted to determine compliance with FDA?s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR), Part 110. During the inspection, our investigators documented numerous insanitary conditions, which caused the ingredients and finished food products manufactured, packed, and/or held at your facility to become adulterated. The adulterated ingredients and finished food products are in violation of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, in that they consist in whole or in part of filthy substances, including rodent excreta pellets, and had been held under insanitary conditions whereby they may have become contaminated with filth.

Evidence of rodent activity was observed in, on, and near foods stored in your spice processing and food storage facility. This evidence included live and dead rodents, rodent excreta pellets, rodent urine stains, and gnawed food packaging. Evidence of rodent gnawing and general rodent activity was observed on several different food product packaging material including, but not limited to, poppy seeds, black pepper, and meat tenderizer. Our FDA laboratory confirmed the findings of rodent excreta pellets, rodent urine stains, rodent hair, and gnawed packaging based on samples taken from your facility during the inspection.

Our investigation of the general conditions in the spice processing and storagefacility revealed: approximate 1" x 10" and 2" x 4" openingsto the outdoors at the bottom of the northeast comer door and approximate 1"x 3" and 2" x 3" openings to the outdoors at the bottom of thesouthwest comer door. In addition, our investigators documented a can of insecticide([redacted]) stored adjacent to finished product in your spice processing an

The above listed violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to insure that your facility is operated in a sanitary manner.

We are aware that on January 21, 2003, you voluntarily destroyed a 50 pound sack of blue poppy seeds, a 50 pound sack of black pepper, a 50 pound sack of meat tenderizer, and two, 50 pound sacks of whole ground mustard. We are also aware that you made promises to our investigators during the inspection to correct some of the observed deficiencies.

At the conclusion of the inspection, our investigators presented to you a list of deficiencies on a Form FDA 483, Inspection Observations. You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further informal notice. Such actions may include the initiation of seizure, injunction, or prosecution actions in federal court.

You should notify this office, in writing, within 15 days of receipt of this letter, of the steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 days, please state the reason for the delay and the time by which the corrections will be completed.

Your response should be directed to Rebecca A. Asente, Compliance Officer, U.S. Food and Drug Administration, 6600 Plaza Drive, Suite 400, New Orleans, Louisiana 70127. Should you have any questions concerning the contents of this letter, you may contact Ms. Asente at (504) 253-4519.

Sincerely,

/s/

F. Dwight Herd

Acting District Director

New Orleans District

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1-Supplements.net 28-Feb-03

Departmentof Health and Human Services            PublicHealth Service

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Food and Drug Administration
5100 Paint Branch Parkway
College Park, Maryland 20740

February 28, 2003

WARNING LETTER

VIA OVERNIGHT DELIVERY

Bryan Green

1 -supplements.net

c/o Powerhouse Supplements

576 Glenrose Lane

Cincinnati, OH 45244

Dear Mr. Green:

The Food and Drug Administration (FDA) has reviewed your web site at the address:http://www.l-supplements.net. This review shows what we believe to be violationsof the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of yourproducts Thermbuterol, Gut Cutter, Dymetadrine Xtreme, and 3-Andro Xtreme. Youcan find the Act and the dietary supplement labeling regulations through linkson FDA?s Internet home page at: http://www.fda.gov.

Under the Act, dietary supplement labeling may include claims about the supplement?s effect on the structure or a function of the human body. To be permissible under the Act, these "structure/function" claims must be truthful and may not be misleading.

The labeling of Thermbuterol, Gut Cutter, Dymetadrine Xtreme, and 3-Andro Xtreme bears structure/function claims that include the following:

• Thermbuterol: "build muscle fast," " enhancing your body?s own muscle-building," and "increasing your lean muscle mass by enhancing your body?s own muscle-building.. *" . "

• Gut Cutter: "feel totally powerful," and ". . . bodybuilding compound."

• Dymetadrine Xtreme: "strength supplementation, " "not only are you stronger and can train with ultra high intensity, " "preserves lean muscle mass," and "supporting lean muscle mass growth."

• 3-Andro Xtreme: "will also help increase strength instantly."

Based on the scientific data available to us, we do not believe that theseclaims are substantiated. If these claims do not have an adequate scientificbasis, they are false or misleading and cause your products to be misbrandedwithin the meaning of Sections 403(a)(1l) and 403(r)(6)(B) of the Act. Section301(a) of the Act prohibits the introduction or delivery for introduction intointerstate commerce of any food, including a dietary

supplement, that is misbranded. Section 301(k) of the Act prohibits the doing of any act with respect to a food, including a dietary supplement, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being misbranded. If you have data which you believe substantiates your claims.

Please share it with us within fifteen (15) working days of your receipt ofthis letter. In addition, except for health claims authorized by FDA, claimsthat a dietary supplement is intended to prevent, diagnose, mitigate, treat,or cure a disease (disease claims), may cause the supplement to be an unapprovednew drug. The Act prohibits the introduction of unapproved new drugs into interstatecommerce. If you are making disease claims for Thermobuterol. Gut Cutter, DymetadrineXtreme. or 3-Andro Xtreme, please be aware that these claims may violate theAct and subject you or the products to regulatory action without further notice.

This letter is not an all-inclusive review of your web site and the productsthat your firm markets. It is your responsibility to ensure that all productsmarketed by your firm comply, with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against the manufacturers and distributors of those products. You should take prompt action to correct any violations identified in this letter. Failure to do so may result in enforcement action without further notice.

Please advise this office, in writing and within fifteen working days of receipt of this letter, as to the specific steps that you have taken to correct any violations and to assure that similar violations do not occur. If corrective action cannot be completed with fifteen working days, state the reason for the delay and the time within which the corrections will be made.

Any reply should be sent to the attention of Compliance Officer Quyen Tienat the above address.

Sincerely yours,

/s/

Joseph R. Baca

Director

Office of Compliance

Center for Food Safety and Applied Nutrition

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A Taste of the Delta, Inc. 27-Jan-03

Departmentof Health and Human Services            PublicHealth Service

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Food and Drug Administration
New Orleans District Office
Nashville Branch
297 Plus Park Blvd
Nashville, TN 37217

January 27, 2003

VIA FEDERAL EXPRESS - NEXT DAY

Mrs. Katherine H. Gregory

A Taste of the Delta, Inc.

1589 Main Street

Tunica, MS 38676

Dear Mrs. Gregory:

Warning Letter 03-NSV-08

An inspection of your smoked catfish processing facility located at 1589 MainStreet, Tunica, Mississippi, conducted by investigators of the Food and DrugAdministration (FDA) on December 10-12, 2002, found significant deviations fromCurrent Good Manufacturing Practice (CGMP) regulations for Seafood HACCP (Title21, Code of Federal Regulations (CFR), Part 123). These deviations, most ofwhich were previously brought to your attention in our letter dated October4, 1999, cause your seafood products to be in violation of section 402(a)(4)of the Federal Food, Drug, and Cosmetic Act (the Act). Seafood HACCP informationis available through links in FDA?s homepage at http://www.fda.gov

Our investigators found the following violations:

• You must have a written HACCP plan which adequately identifies each food hazard that is reasonably likely to occur, to comply with 21 CFR 123.6(c)(l). Your HACCP plan fails to identify Clostridium botulinum toxin formation as a hazard which is reasonably likely to occur in your refrigerated, ready-to-eat smoked catfish in modified atmospheric packaging (heat sealed plastic).

• Your HACCP plan does not list satisfactory monitoring procedures for the hot smoking process; your HACCP plan does not list any monitoring procedures to ensure that hot smoked fish is properly cooled to below 40 degrees F within a specified timeframe; and your HACCP plan does not list any monitoring procedures to ensure the prevention of the growth of Clostridium botulinum and prevention of toxin formation in the heat sealed plastic packages, to conform with 21 CFR 123.6(c)(4).

• You must have a written HACCP plan to control each food hazard that is reasonably likely to occur, to comply with 21 CFR 123.6(b). However, you continue to lack a HACCP plan to address the hazard of Clostridium botulinum toxin formation and pathogen growth in your smoked catfish product.

• You must take appropriate corrective action when a process deviation from your HACCP plan occurs, to comply with 21 CFR 123.7(c)(3). Five instances were identified during the last FDA inspection in which the cooking temperature and/or time did not meet the critical limit parameters for the hot smoking process and no corrective action was implemented.

• You must review or obtain review by a HACCP trained individual to determine the acceptability of the affected product for distribution, when a deviation from a critical limit has occurred in the absence of a predetermined corrective action plan, to comply with 21 CFR 123.7(c)(2). As previously noted, five instances were identified during the last inspection in which product was distributed even though the temperature and/or time did not meet the critical limit parameters for the hot smoking process.

• Your HACCP plan identifies a critical control limit that may not be adequate to properly control the hazard, to comply with 21 CFR 123.6(c)(3). Y our salting method and your cooking method are outside the recommended limits identified in the Seafood Hazards Guide. Although you are salting the catfish up to 10 hours longer than your process authority recommended, you do not have subsequent sample analysis to verify the water phase salt content is satisfactory. Also, the smoking process identified in your HACCP plan does not match the process that you actually complete. Your HACCP plan must identify the minimal temperature and time required (145 degrees F/30 minutes) for this smoking/cooking process.

• You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(c).

• You must include in monitoring records the date and/or time of the activity the record reflects and the initials of the person performing the operation, to comply with 21 CFR 123.9(a). You must document the start and end time for the brining process, the start and end time for the smoking/cooking process, and the start and end time for the cooling process for the finished product smoked fish, to verify your critical limits are met.

• A HACCP trained individual must review all records which document monitoring of critical control points, the taking of corrective action in accordance with 21 CFR 123.7, and instrument calibration records, to comply with 21 CFR 123.8(a)(3).

• You must have a written HACCP plan that lists verification steps that are adequate, to comply with 21 CFR 123.6(c)(6). Y our firm?s HACCP plans do not require a review of monitoring, corrective action and verification records within one week of preparation.

• Your firm has not calibrated your thermometers, to comply with 21 CFR 123.8(a)(2).

• You must implement the monitoring procedures listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm does not routinely monitor the temperature of the catfish during the smoking operation, the cooling process after smoking, or the refrigerated storage of the finished product.

• Your HACCP plan must be signed and dated, either by the most responsible individual onsite at the processing facility or by a higher level official in your firm, to signify that the plan has been accepted for implementation by your firm, to comply with 21 CFR 123.6(d).

The above is not intended as an all-inclusive list of deviations. As a seafood processor, you are responsible for assuring that your plant operates in compliance with the Act, the Seafood HACCP regulations and the Current Good Manufacturing Practice regulations (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure and/or injunction.

You should notify this office in writing within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made and explain preventative measures to guard against future violations.

Your response should be directed to Kari L. Batey, Compliance Officer, at 297 Plus Park Boulevard, Nashville, TN 37217.

Sincerely,

/s/

Carl E. Draper

Director, New Orleans District

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