Inspections, Compliance, Enforcement, and Criminal Investigations
Procesadora El Cangrejito Del Mar C.A. (Procamar, C.A.) 10/24/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
OCT 24, 2011
Reference No. 215554
VIA EXPRESS MAIL
Mr. Edwin Munoz
Procesadora El Cangrejito Del Mar (PROCAMAR)
Av. Principal de Ia Guajira
La Canada De Urdaneta, Estado Zulia
Dear Mr. Edwin Munoz:
On April 7, 2011 and April 8, 2011, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Av. Principal de Ia Guajira, La Canada De Urdaneta, Estado Zulia, Venezuela. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). The inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm. We received your responses to the FDA-483 on April 29, 2011 and your translated HACCP records on August 18, 2011. Our evaluation of the inspectional information, coupled with our evaluation of the information submitted within your responses, concludes that your corrective actions to date are not adequate to address the deviations noted during the inspection and that your HACCP plan continues to have problems.
In accordance with Title 21, Code of Federal Regulations, Section 123.6(g) [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 crabmeat products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
FDA has recently published a 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e., the Hazard Guide). You may find the Act, the seafood HACCP regulation, and the Hazard Guide through links in FDA's home page at www.fda.gov. For additional information and guidance concerning the hazards of pathogen growth, please refer to chapters 12 and 16 of 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.
The deficiencies in your compliance with the seafood HACCP regulation are as follows:
1. 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, your firm's HACCP plan provided during the inspection of your firm for "Pre Cooked Crab Meat" does not list the critical control point of:
A. In-Process Refrigerated Storage for cooked crab to control growth of bacterial pathogens. After cooking, your firm immediately cooling crabs with large powerful fans for (b)(4) to preliminarily cool the crabs and then places the maintained at for (b)(4) further cooling before processing the following day. The day next, you store your crabmeat in an intermediate cooler for two hours before proceeding to the picking step. FDA recommends using a continuous temperature recorder to ensure the cooler(s) is kept at 40 °F or below to control the hazard of pathogen growth and toxin formation; and
B. Cooling of cooked crabs to control pathogen growth. FDA recommends that cooked seafood be cooled from 140 °F to 70 op within 2 hours, followed by cooling from 70 °F to 40 °F within an additional 4 hours to control pathogen growth.
2. You must have a HACCP plan that, at a minimum, 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 "Pre Cooked Crab Meat Product":
A. Lists a monitoring procedure at the Cooking critical control point that is not adequate to control biological pathogens. Specifically, your listed monitoring procedures (b)(4) are inadequate. FDA recommends a continuous monitoring parameters (e.g. temperature and psi) with a visual check of the recorded data.at least once per batch; and
B. Lists a monitoring procedure at the Refrigerated Storage critical control that is not adequate to control biological pathogens. Specifically your HACCP states you will monitor the refrigerated room temperature (b)(4). FDA recommends that you monitor your cooler temperatures continuously with a daily review of the records to assure that your critical limits have not been exceeded.
3. 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 "Pre Cooked Crabmeat" does not list the food safety hazards of allergens.
4. 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 "Pre Cooked Crab Meat Product" at the "Cooking" and "Refrigerated Storage of Finished Product" critical control points to control pathogens is not appropriate. Specifically, your corrective actions fail to ensure that adulterated products do not enter commerce. This can be accomplished by destroying the article of food or diverting adulterated products to non-food use.
You should respond in writing within thirty (30) 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 thirty (30) 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.accessdata.fda.gov/cms_ia/importalert_25.html
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: Stuart A. Feldman, 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 Mr. Feldman by phone at (240) 402-3006 or via email at firstname.lastname@example.org
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition