21st Century Sports Nutritionals, Inc. 13-Jun-02

Departmentof Health and Human Services            PublicHealth Service

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Food and Drug Administration
Rockville, MD 20867

WARNING LETTER
June 13, 2002

President/Owner
21^st Century Sports Nutritionals, Inc
745 Hollywood Blvd., N.W.
Fort Walton Beach, Florida 32548

Ref: 02-HFD-312-05

Dear Sir or Madam

This letter is written in reference to your firm?s marketing of the products,Phenylkinetics, Libido Magic for Men, and Libido Magic for Women. Accordingto your Internet web site, http://www.2lcenturysports.com, Phenylkinetics contains,among other ingredients, norephedrine HCI, Libido Magic for Men contains, amongother ingmdiellts, 1R, 2s norephedrine HCI, and Libido Magic for Women contains,among other ingredients, 1R, 2s not-ephedrine HCI. Statements on your Internetweb site, indicate that these products are intended for stimulating sexual interestand function and/or for weight loss.

Although your web site represents these products as dietaty supplements, forexample by statements such as, " . . .Energy Supplements.. .?* and ".. .sports supplements.. . *?, they cannot be so considered because the norephedrineHCI used in your products appears to be a synthetic compound that is not derivedfrom any botanical source. Synthetic norephedrine HCI is not plant-derived andcannot, therefore, be considered a constituent or extract of a botanical source.Consequently, FDA has determined that synthetic ephedrine alkaloids am not ?dietaryingredients" as defined in the Federal Food, Drug and Cosmetic Act [theAct, Section 201(ff)(1)].

Therefore, products containing synthetic ephedrine alkaloids do not fall underthe dietary supplement regulatory scheme. Based on their intended uses, to affectthe structure or function of the body, these products are drugs within the meaningof Section 201(g) of the Act. Such products are considered drugs when theirintended use is established by structure injunction claims, such as those thatappear on your web site. Some of the claims on your Internet web site, http://www.21centurysports.com,from which these products may be ordered, state, for example, ". . Phenylkinetics..designed to promote weight loss through rapid metabolization of stored fat withoutcausing that bouncing off the walls? feeling?. , .?*, ". , . Libido Magicfor Men.. .increased sexual function by raising testosterone levels and enhancingblood circulation needed to support firmer, longer lasting erections...,? and" . . Libido Magic for Women.. . stimulate female sexual desire, intensifyorgasm strength and longevity while heightening sexual satisfaction.. .".

As drugs, the labeling claims made for these products subject them to the requirements for new drugs [Section 201(p) of the Act] because there is no evidence that these products are generally Page 2 - 21" Century Sports Nutritionals recognized as safe and effective for their claimed uses.

Under Section 505(a) of the Act, a "new drug" may not be introducedor delivered for introduction into interstate commerce unless an FDA-approvednew drug application is in effect for such drug. Because your products are notthe subjects of approved NDA?s, they may not be marketed in the United Statesand their continued distribution violates Section 505 of the Act.

This letter is not intended to be an all-inclusive review of your Internet web site nor all labeling and products your firm markets. The violation of the Act described above is not intended to be an all-inclusive list of violations concerning your firm and its products. It is your responsibility to ensure that all products marketed by your firm, including other synthetic ephedrine alkaloid products, are in compliance with the Act and its implementing regulations.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the FDA without further notice. The Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify this office within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the attention of Ms. Vesna Stanoyevitch, Compliance Officer, at the Food and Drug Administration, Center For Drug Evaluation and Research, Office of Compliance (HFD-310). Metropark North I, 7520 Standish Place, Rockville, MD 20855.

Sincerely yours,

/s/

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

 

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A. Friscia Seafoods Inc 23-Apr-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

Telephone: 510-337-6700

VIA FEDERAL EXPRESS

Our Reference: 2945025

April 23, 2002

WARNING LETTER

Anthony S. Friscia, President

A. Friscia Seafoods, Inc.

555 Francisco Street

San Francisco, California 94133

Dear Mr. Friscia:

On November 19-20 and December 3, 2001, we inspected your seafood processingfacility, located at 555 Francisco Street, San Francisco, CA. We found thatyou have serious deviations from the seafood HACCP regulations in Title 21,Code of Federal Regulations, Part 123 (21 CFR 123). These deviations cause yourAhi, Mahi, Tombo Tuna, and Cooked Crab to be adulterated within the meaningof Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act),in that the fishery products have been prepared, packed, and held under insanitaryconditions whereby they may be rendered injurious to health. You may find theAct and the seafood HACCP regulations through links in FDA? s home page at www.fda.gov.See attached handout, which gives information on how to obtain the Fish &Fisheries Products Hazards & Controls Guidance, 3ti edition, June 2001.

Your serious HACCP deviations are as follows:

1. You must have a HACCP plan that lists the critical limits that must be metto comply with 21 CFR 123.6(c)(3). However, your firm? s HACCP plans for Ahi,Mahi, and Tombo Tuna list critical limits, "Cooler temp not to exceed [redacted]degrees F for more than 4 hours in a 24 hour period. Cooler temp not to exceed[redacted] degrees F control cumulative," at the receiving critical controlpoint that is not adequate to control histamine formation.

FDA recommends that either:

All lots received are accompanied by transportation records (e.g., temperaturerecording chart) that show the fish were held at or below 40?F throughout transit

OR

For fish held under ice or other cooling media at the time of delivery--thereis an adequate quantity of ice or other cooling media to completely surroundthe product

OR

For fish delivered with a total transit time of 4 hours or less, the internaltemperature of a representative number of fish in the lot at the time of deliveryis not more than 40?F.

2. You must have a HACCP plan that lists the critical control points to complywith 21 CFR 123.6(c)(2). However,

1. Your firm?s HACCP plans for Ahi, Mahi, and Tombo Tuna do not list the critical control point of storage for controlling the food safety hazard of scombrotoxin formation. FDA recommends that refrigerated seafood products be held at 40?F or less and that the temperature be monitored continuously by means of a temperature data recorder or by using an alarm system.


2. Your firm?s HACCP plan for Cooked Crab does not list the critical control point of storage for controlling the food safety hazard of bacterial pathogen growth. FDA recommends that refrigerated seafood products be held at 40?F or less and that the temperature be monitored continuously by means of a temperature data recorder or by using an alarm system.

3. Since you chose to include corrective actions in your HACCP plan, your describedcorrective actions must be appropriate to comply with 21 CFR 123.7(b). However,your corrective action plan for Cooked Crab at the cooking critical controlpoint is not appropriate. Your corrective action plan does not address the correctiveaction to be taken when your time-temperature critical limit is not met (i.e.,[redacted]minutes at [redacted] degrees F). Your corrective action plan should also addresscorrecting the cause of the deviation and ensuring that unsafe product (i.e.,under-processed product) does not reach consumers.

4. You must maintain sanitation control records that document the monitoringand corrections applied to the following to comply with 21 CFR 123.1l(c):

• Safety of water


• Condition and cleanliness of food-contact surfaces


• Prevention of cross-contamination


• Maintenance of hand-washing, hand-sanitizing, and toilet facilities


• Protection from adulterants


• Labeling, storage, and use of toxic compounds


• Employee health conditions


• Exclusion of pests

5. You must have a HACCP plan that lists the food safety hazards that are reasonablylikely to occur, to comply with 2 1 CFR 123.6(c)( 1). However, your firm?s HACCPplan for Cooked Crab does not list the food safety hazard of natural toxins.

6. You must adequately monitor sanitation conditions and practices during processing,to comply with 21 CFR 123.1 l(b). However, your firm did not monitor the followingareas of sanitation with sufficient frequency to ensure control:

a. Your firm failed to monitor the condition and cleanliness of food contactsurfaces as evidenced by our investigator observing an employee using a telephonewhile wearing latex gloves and subsequently handling ready-to-eat crabmeat withoutwashing and sanitizing the gloves.

b. Your firm failed to prevent cross-contamination from insanitary object tofood or food-packaging material as evidenced by our investigator observing employeesroutinely packing ready-to-eat crabs into recycled boxes that were previouslyused to package fresh and frozen crabs.

At the conclusion of the inspection, the deviations were listed on Form FDA483 and discussed with you. A copy of this form is enclosed for your ready reference.This list is not meant to be an all-inclusive list of violations. You are responsiblefor ensuring that your processing facility operates in compliance with the Act,the seafood HACCP regulations, and the Good Manufacturing Practice regulations(21 CFR 110).

We may take further action if you do not promptly correct these violations.For instance, we may take further action to seize your products and/or enjoinyour firm from operating.

Please respond in writing within fifteen (15) working days of receipt of thisletter. More than four months have elapsed since FDA inspection. Please providethis office with information on what progress you have made in achieving FDAcompliance with the seafood HACCP regulations. You may wish to include in yourresponse documentation that would assist us in evaluating your corrections.If you cannot complete all corrections before you respond, we expect that youwill explain the reason for your delay, and state when you will correct anyremaining deviations.

Your response should be directed to: Ms. Harumi Kishida, Compliance Officer,U.S. Food and Drug Administration, 143 1 Harbor Bay Parkway, Alameda, CA 94502-7070.

If you have any questions regarding any issue in this letter, please contactMs. Kishida at (510) 337-6824.

Sincerely,

Dennis K. Linsley

District Director

San Francisco District

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A-Vox Systems, Inc. 18-Apr-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145

April 18, 2002

Ref: 2002-DAL-WL-13

WARNING LETTER

CERTIFIED MAIL

RETURNED RECEIPT REQUESTED

Mr. Albert P. Shepherd, President

A-VOX Systems, Inc.

28267 Ruffian Drive

Fair Oaks Ranch, Texas 78015-4809

Dear Mr. Shepherd:

On March 12 through 14, 2002, our FDA investigator conducted an inspectionof your device manufacturing facility located at 12001 Network Blvd., BuildingF, Suite 210, San Antonio, Texas. Our investigator determined that your firmmanufactures several models of oximeters, which are used for whole blood measurementof total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, and oxygencontent, and disposable cuvettes. These products are medical devices as definedin Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

At the conclusion of the inspection, our investigator issued a list of InspectionalObservations (Form FDA-483) to you listing significant deviations from CurrentGood Manufacturing Practices (CGMP). Your devices are adulterated within themeaning of Section 501(h) of the Act in that the methods used in, or the facilitiesor controls used for their manufacturing, packing, storage, or installationare not in conformance with the CGMP requirements of the Quality System Regulation,as specified in Title 21, Code of Federal Requlation (CFR), Part 820. SignificantCGMP deviations include, but are not limited to, the following:

1. Failure to maintain device history records to demonstrate the devices aremanufactured in accordance with the device master record [21 CFR 820.184].

For example, your firm did not keep test records [Individual Device Records]as required by your procedures for the six oximeter devices cited in FDA-483item 1.

2. Failure to establish and maintain procedures to control product that doesnot conform to specified requirements [21 CFR 820.90]. For example, your firmfailed to maintain the non-conforming reports (NCR) as required by your proceduresfor the four oximeter devices cited in FDA-483 Item 5.

3. Failure to establish and maintain procedures for implementing correctiveand preventive action [21 CFR 820.100]. For example, your firm had not investigatedand documented the device failure causes or completed the corrective actionreports (CAR) for the non-conforming oximeter devices listed in FDA-483 Items1, 2, and 5 in order to identify the actions needed to prevent recurrence ofthe device failures.

4. Failure to maintain procedures to ensure all purchased or otherwise receivedproducts and services conform to specified requirements [21 CFR 820.50] seealso 820.80]. For example, your firm failed to ensure that the supplier of themain computer board (i.e., [redacted] Main Board) documented all of the requiredtest results to indicate the supplier?s quality acceptance of the [redacted]computer boards manufactured and delivered to your firm.

5. Failure to establish and maintain schedules and maintenance activities forthe adjustment, cleaning, and other maintenance of manufacturing equipment [21CFR 820.70(g)(l)]. For example, your firm does not have a maintenance documentationof maintenance activities for the [redacted] and the [redacted] [FDA-483 items3 and 4].

Your firm orally promised our investigator that it would correct FDA-483 Items1, 2, 5, and 6 and placed FDA-483 Items 3 and 4 under consideration. You havenot provided a written response confirming your promise and outlining specificsteps your firm has taken or will take to correct the above GMP deficiencies(although your firm stated its intention to respond in writing to the FDA-483within one month of the inspection, to date we have not received such a response).

This letter is not intended to be an all-inclusive list of deficiencies atyour facility. It is your responsibility to ensure adherence to each requirementof the Act and the regulations. The specific violations noted in this letterand in the FDA-483 issued at the close of the inspection may be symptomaticof serious underlying problems in your firm?s manufacturing and quality assurancesystems.

You are responsible for investigating and determining the causes of the violationsidentified by the FDA. If the causes are determined to be systems problems,you must promptly initiate permanent corrective actions.

Federal agencies are advised of the issuance of all Warning Letters about devicesso that they may take this information into account when considering the awardof contracts.

You should take prompt action to correct these violations. Failure to promptlycorrect these violations may result in regulatory action being initiated bythe Food and Drug Administration without further notice. These actions include,but are not limited to, seizure, injunction, and/or civil penalties.

Please provide this office in writing within 15 working days of receipt ofthis letter a report of the specific steps you have taken, or will take to identifyand correct any underlying systems problems necessary to assure that similarviolations will not recur. If corrective action cannot be completed within 15working days, state the reason for the delay and the time frame within whichthe corrections will be completed. Your reply should be directed to Thao Ta,Compliance Officer, at the above letterhead address.

Sincerely,

Michael A. Chappel

Dallas District Director

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