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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FACTORIA DEL LAGO C.A.

 

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD

Warning Letter
I.D. # 116249

August 5, 2010

VIA OVERNIGHT MAIL

Factoria Del Lago
Calle 76 Entre Av 3H Y 3Y Sector A Lago
EDIF. Villa Ota II, 3ER Piso Office 33-34
Maracaibo, VE-V
Venezuela

Dear Sir/Madame:

On April 22 through 26, 2010, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States: Kingmar Seafood Corporation, located at 1301 NW 89th Court, Suite 206, Miami, Florida 33172-2317. That importer was found to be importing cooked (i.e., pasteurized) crab meat from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for your "Cooked Crab Meat." Our evaluation of that HACCP plan (copy attached) revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 cooked crab meat products 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 and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

We note the following deviations:

1. You must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazard that are reasonably likely to occur and have a HACCP plan that, at a minimum, list 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, your firm's HACCP plan for your cooked crab meat fails to list the following two critical control points. Specifically,

a. The SOP that accompanies your HACCP plan document (i.e., page 2 of the SOP) states "Within (b)(4), the crab meat is pasteurized." This appears to indicate that the crab meat is held in storage, after being packed in the metal cans, for up (b)(4) before pasteurization. Your HACCP plan, however, does not include a refrigerated storage critical control point, following packing but before pasteurization, to control the hazard of pathogen growth, including Clostridium botulinum and possibly Staphylococcus aureus growth and potential toxin formation.

b. The SOP (page 2) also states that "During the pasteurization process, the can of picked crab meat is (b)(4) as a critical control point to control the hazard of pathogen growth, including Clostridium botulinum. Moreover, we suggest a critical limit associated with a measurable residual level of chlorine in the water, to prevent introduction of pathogens; or alternatively that the water undergo an ultraviolet treatment to prevent introduction of pathogens during the cooling.

2. 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 Part 123.7(b). However,

a. The listed corrective action at the "Pasteurization" critical control point that includes sampling (b)(4) of product for the presence of pathogens is inadequate. If the pasteurization process does not meet the listed critical limit requirements, then random testing of the lot cannot provide assurance of safety of the entire lot.

b. The corrective actions listed at the processing critical control points, including backing, picking and packing do not address the cause of the deviation.

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. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For
instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import_ial6120.html.

In addition, we note that the monitoring procedures listed in your HACCP plan reference the use of a recording thermomder and continuous checks at the "Refrigerated Storage" critical control point. However, the document entitled (b)(4). Please verify whether or not your firm has equipment capable of monitoring and recording cooler storage temperatures on a continuous basis, as recommended.

This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (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: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov

Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition

cc:
Calle 100 c.c. Aeropuerto
Loacal 2B Sabaneta
Maracaibo, Venezuala