Valley Wholesale Produce and Seafood 5/2/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office 6000 Metro Drive Suite 101 Baltimore, MD 21215-3215 Telephone: (410) 773-6454 Fax: (410) 779-5705

 

FEI: 3008817650

WARNING LETTER

CMS# 178632

 

May 2, 2011

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

Mr. Michael D. Bond, Owner

Valley Wholesale Produce and Seafood

24 W Hart Street

Winchester, VA 22601-4513

 

 

Dear Mr. Bond:

 

We inspected your produce and seafood warehouse, located at 24 W Hart Street, Winchester, VA 22601-4513 on March 18 and March 24, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your canned pasteurized crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

 

Your significant violation was as follows:

 

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for canned pasteurized crabmeat to control the food safety hazards of pathogens to include Clostridium botulinum as a result of time/temperature abuse.  In addition, your firm does not have a HACCP plan for cooked shrimp to control the hazards of pathogens.

 

In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act [21 U.S.C. § 350(d)] and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.

 

The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.

 

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:

 

U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857

 

When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.

 

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

 

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

 

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Kristy Leslie, Compliance Officer, 1040 University Boulevard, Suite 106, Portsmouth, VA 23703. If you have questions regarding any issues in this letter, please contact Ms. Leslie at 757-483-7042.

 

 

Sincerely,

/S/ 

                                                                                                                                                                                        Evelyn Bonnin

District Director 

 

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Le Natural, Inc. 5/2/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Juan District Compliance Branch 466 Fernandez Juncos Avenue San Juan Puerto Rico 00901-3223 Telephone: 787-474-9500 FAX: 787-729-6658

May 2, 2011

WARNING LETTER

11-SJN-WL-09

VIA OVERNIGHT MAIL

Mr. Jose Lazzof
President
Le Natural, Inc. and 9-12 Corp.
PMB Dept 388
HC-O1 Box 29030
Caguas, PR 00725

Dear Mr. Lazzof:
 

The United States Food and Drug Administration (FDA) reviewed the labels for your Elevate enhanced fiber water (lemon and orange flavor) products. We examined the product labels and your website at www.elevatewaters.net in April of 2011. Based on our review, we have
determined that your Elevate enhanced fiber water (lemon and orange flavor) products are misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 343]. We also determined that your products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)). The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov.

Unapproved New Drug

We have determined that your website www.elevatewaters.net  is labeling for your Elevate enhanced fiber water (lemon and orange flavor) products under section 201(m) of the Act [21 U.S.C. § 321(m)) because the website address appears on the labels of these products. The
following is an example of a claim observed on your website:

• "Helps manage diabetes."

Your products are not generally recognized as safe and effective for the above referenced condition and therefore, the products are "new drugs" as defined under section 201(p) of the Act [21 U.S.c. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Misbranded Food

Your Elevate enhanced fiber water (lemon and orange flavor) products are misbranded within the meaning of section 403(r)(1)(B) of the Act [21 US.C. § 343(r)(1)(B)] because the labeling for these products bears unauthorized health claims. Your website bears the following
unauthorized health claims:

• "A diet rich in fiber can reduce the risk of cardiovascular disease, obesity, an (sic) high blood pressure."

• "The direct benefits of fiber. .. Helps to reduce the risk of cancer."

These health claims misbrand your products because they have not been authorized either by regulation (see section 403(r)(3)(A)-(B) of the Act [21 US.C. § 343(r)(3)(A)-(B)]) or under authority of the health claim notification provision of the Act (see section 403(r)(3)(C) of the Act
[21 US.C. § 343(r)(3)(C)]). Further, although FDA has issued a regulation authorizing a health claim associating fiber with a reduced risk of cancer (21 CFR 101.76), the claim on your website that states "The direct benefits of fiber. .. Helps to reduce the risk of cancer" does not meet the requirements for this claim. For example, under 21 CFR 101.76(c)(2)(C) the claim is limited to grain products, fruits, and vegetables that contain dietary fiber. Your products do not fall under any of these categories, and therefore do no meet the requirements to make this claim.

Your Elevate enhanced fiber water (lemon and orange flavor) products are also misbranded under Section 403(i)(1) of the Act [21 US.c. § 343)(i)(1)] because the products fail to bear an adequate common or usual name of the food as specified by 21 CFR 101.3(b)(2). Specifically,
the labels for your products bear the name "Enhanced Fiber Water." Given that your products are sweetened with sugar and water is a substance that is free of calories and sweeteners, identifying this beverage as an orange or lemon flavored fiber water does not appropriately
describe the product as required under 21 CFR 101.3(b)(3).

This letter is not meant to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations
described above. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction [21 US.C. §§ 332 and 334].

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and to ensure similar violations do not occur. You should include in your response documentation such as copies of new labels, or other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, you should explain the reason for your delay and the time frame within which any remaining violations will be completed.

Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Rafael Nevarez, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issues in this letter, please
contact Mr. Nevarez at (787) 474-9545.

Sincerely,

/s/

Maridalia Torres
District Director
San Juan District Office
 

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Dani Jacq, Inc 5/2/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office Central Region 6000 Metro Drive, Suite 101 Baltimore, MD  21215 Telephone: (410) 779-5455 FAX: (410) 779-5707

FEI: 3003751705                                                                                                                                                 

WARNING LETTER
CMS #169274

May 2, 2011

Certified Mail
Return Receipt Requested
 
Mr. Kenneth R. Kell, President
Dani Jacq, Inc. dba The Home Fresh Foods Company
1806 Old Eastern Avenue
Baltimore, MD 21221-1429

Dear Mr. Kell:

We inspected your seafood processing facility, located at 1806 Old Eastern Avenue, Baltimore, MD 21221 on January 3 to January 18, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your ready-to-eat Tuna Pasta Salads, ready-to-eat Shrimp Pasta Salads, Crab Soup, and Shrimp and Corn Chowder are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.  You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

• You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and  (b). However your firm does not have HACCP plans for:

a. Ready-to-eat Tuna Pasta Salad to control the food safety hazards of pathogen growth, histamine formation, and allergens.

b. Ready-to-eat Shrimp Pasta Salad to control the food safety hazards of pathogen growth, allergens, and food intolerance substances.

• You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for:

a. “Crabmeat HACCP” which includes your Crab Soup does not list the food safety hazards of allergens;

b. “Soups, Non-Meat & Poultry”, which includes your Shrimp and Corn Chowder does not list the food safety hazards of allergens and food intolerance substances (sulfites).

• You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However,

a. Your firm’s HACCP plan for “Crabmeat HACCP”, which includes your Crab Soup, does not list the critical control points for raw material storage (pasteurized canned crabmeat), cooking, processing (filling and cool-down), and finished product storage for controlling the food safety hazard of pathogens to include Clostridium botulinum toxin formation;

b. Your firm’s HACCP plan for “Soups, Non Meat & Poultry”, which includes your Shrimp and Corn Chowder does not list the critical control point for cooking, filling, and finished product storage for controlling the food safety hazard of pathogens to include C. botulinum toxin formation.

• You must implement the monitoring procedures and frequency that you have listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(4).  However, your firm did not follow the monitoring procedures for receiving pasteurized crabmeat upon the receipt of each shipment to control pathogen growth and toxin formation listed in your HACCP plan for “Crabmeat HACCP” which includes your Crab Soup. Specifically, a representative of your firm stated that you have not implemented monitoring procedures at the receiving pasteurized crabmeat critical control point to control pathogen growth and C. botulinum toxin formation. The monitoring procedures were not performed between January 5, 2010 and January 13, 2011.

• You must have a HACCP plan that lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4).  However, your firm’s HACCP plan for “Crabmeat HACCP” for Crab Soup lists an inadequate monitoring procedure at the “Receiving Pasteurized Crabmeat” critical control point to control “Growth of the Pathogen C. botulinum”. Specifically, your monitoring procedure,

a. Under “What” states that you will monitor the “Temperature of a representative number of pasteurized crabmeat containers per shipment,” however you do not state whether you will be monitoring internal crabmeat container temperature or crabmeat container surface temperature.

b. Under “How” states that you will perform a “Visual check” to monitor temperature, however you do not list the instrument used to monitor the product temperature.

c. In addition, you do not list how you will ensure that transport time for transportation is less than 4 hours. Taking a one time temperature at receipt is adequate only when transit times are short, for example under 4 hours.

• Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for “Crabmeat HACCP” for Crab Soup at the “Receiving Pasteurized Crabmeat” critical control point to control “Growth of the Pathogen C. botulinum” is not appropriate. You do not list how you will correct the cause of the deviations, for example, discontinuing use of the supplier until evidence is obtained that transportation handling practices have improved.

• You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3).  A critical limit is defined in 21 CFR  123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for “Soups, Non Meat & Poultry”, which includes your Shrimp and Corn Chowder, lists a critical limit (b)(4) at the “Chilling Finished Product” critical control point that is not adequate to control pathogen growth and toxin formation. Specifically, you fail to list an actual value.

We received your letter dated February 21, 2011 responding to the FDA-483 issued on 1/18/11 and re-issued as Amendment 1 on 1/28/11. We have evaluated your response. Although you begin to address FDA’s concerns, your response does not adequately address the observations noted in the FDA-483.

Your firm has disconnected the continuous temperature recorder of your walk-in coolers, and you currently monitor the temperature of the walk-in coolers visually. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that readings are accurate, and a daily check of the monitoring equipment itself to ensure that it is operating properly.

For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycutt@fda.hhs.gov.

Sincerely yours,

/s/

Evelyn Bonnin
District Director

 

 

 

 

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