Inspections, Compliance, Enforcement, and Criminal Investigations
Pesquera Alvarez y Alvarez Ltda 12/13/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
December 13, 2013
VIA EXPRESS DELIVERY
Sergio Orlando Alvarez Navarro
Pesquera Alvarez y Alvarez Ltd.
Huerto 68-A final de av Espana
Puerto Natales, Magallanes
Reference number: 414183
Dear Mr. Navarro:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Pesquera Alvarex y Alvarez Ltd., located at Huerto 68-A final de av Espana, Puerto Natales, Magallanes, Chile 61600 on May 9 and 10, 2013. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110).
At the conclusion of the inspection, the FDA investigator issued a FDA-483, Inspectional Observations, listing the observations noted at your firm. We acknowledge receipt of your response sent via email on May 29, 2013. Your response included several documents and descriptions of corrections you have made. However, your response did not include a revised HACCP plan for frozen, vacuum-packed cooked king crabmeat. We have reviewed the documentation you provided and find that the response was not adequate, as further described in this letter.
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 (FD&C Act), [21 U.S.C. § 342(a)(4)]. Accordingly, your frozen, vacuum-packed cooked king 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. 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.
We note the following significant deviations:
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 for frozen, vacuum-packaged cooked king crab meat does not list the following critical control points necessary to control the food safety hazard of pathogen contamination and growth:
a. (b)(4) immediately following the cook step.
During the inspection, our investigator noted that your firm conducts significant handling of the cooked crab meat after cooking, while the crabs are (b)(4). This creates a condition conducive to post-cook contamination and pathogen growth. FDA recommends your firm include a critical control point for the cooling process that ensures the cooked crabs are cooled from 57.2⁰C to 21.1⁰C within 2 hours with further cooling to 4.4⁰C within an additional 4 hours.
b. Processing occurring after (b)(4) that includes (b)(4).
These steps were observed as taking up to (b)(4). Because extended time exposures to temperatures (b)(4) creates conditions conducive to pathogen growth, you need to include a critical control point for these processing steps in your plan that ensures that ambient temperatures remain at or (b)(4) for the entire duration of processing. Once included as a critical control point in your plan, we recommend monitoring the temperatures every 2 hours.
Additionally, according to your records, your firm (b)(4) in your (b)(4) the finished product. When conducting your hazard analysis, we recommend that your firm consider including a critical control point for this (b)(4) period to ensure the product is held under refrigeration where the temperature is maintained at 4.4⁰C or less. We additionally recommend the use of equipment capable of continuously temperature monitoring and recording the cooler temperatures.
2. 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 frozen, vacuum-packed cooked king crab meat does not list the food safety hazard of Clostridium botulinum germination, growth and toxin formation in frozen, vacuum-packaged molded crabmeat. We recommend a critical control point that ensures each individual unit of product is labeled with a “keep frozen” statement, coupled with handling instructions (e.g., Important, keep frozen until used, thaw under refrigeration immediately before use”).
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation that would assist us in evaluating your corrections, 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 or plans; any verification records; and any other useful information. If you cannot complete all corrections within 15 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 (21 CFR Part 123) is Import Alert #16-120. This alert can be found on FDA’s web site at:
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation 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.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the Food and Drug Administration, Attention: Philip Bermel, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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. Bermel via email at Philip.Bermel@fda.hhs.gov
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition