| Public Health Service Food and Drug Administration |
| Washington, DC |
Department of Health and Human Services
WARNING LETTER
February 02, 2010
VIA OVERNIGHT MAIL
Mr. Mohamed Bicha
Owner and General Manager
Societe Nouvelle Averio Maroc
BP 117
Agadir, Morocco
Dear Mr. Bicha:
On October 5 and 6, 2009, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your canned seafood processing facility, located at Ait Mellord, Route Biougra & Agadir, Agadir, Morocco. Upon further review of our investigator's inspection report and findings during the inspection, we determined that you have serious violations of the United States' Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), referred to as the seafood HACCP regulation. In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (the Act), [21 USC § 342(a)(4)]. Accordingly, your firm's canned sardines are adulterated, in that the products 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 acknowledge your firm's October 12, 2009, response to the Form FDA-483 and have determined that you adequately addressed the deviations from the low-acid canned food regulations (21 CFR 108 and 113); however, after further review of your Seafood HACCP plan, we determined that you have significant deviations from the Seafood HACCP requirements.
Your significant violations are as follows:
• You must have a HACCP plan that lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). However, your firm's HACCP plan for "Canned Sardine and Mackerel" lists critical limits that are not adequate to control the hazard of scombrotoxin (histamine) formation in your product. Specifically:
o Your plan identifies "time between hour of death and icing should not exceed 6 hours" to be recorded on harvest vessel records as a strategy to prevent the hazard of scombrotoxin (histamine) formation at the "Reception at the seaport" critical control point (CCP). In addition to the time element between death and icing on board vessels, we recommend a control strategy of monitoring the internal temperatures of the fish as they are off-loaded from the vessels, which is not included in your HACCP plan. Monitoring these internal temperatures helps to ensure appropriate onboard handling and chilling.
o Your plan identifies the critical limit, "Presence of ice" at the "Reception" CCP. FDA recommends a critical limit that specifies that the fish be completely surrounded by ice at the time of delivery. In addition, baskets of fish were observed to have inadequate ice by our investigator and internal temperatures of those fish were found to be 11.6°C (52.9°F).
• 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 "Canned Sardine and Mackerel" lists a monitoring procedure at the "Reception" CCP that is not adequate to control the hazard of scombrotoxin (histamine) formation. Specifically, your plan lists a monitoring procedure of controlling the "level of histamine" by using the "Fluorimetre" method on "Each lot"; however, the HACCP plan does not indicate the number of sample units to be tested from each lot as part of the procedure. FDA recommends a minimum of 18 units per lot; with a greater number of units sampled if the variability within a lot is expected to be large. In addition, the procedure in the HACCP plan does not provide details about your firm's sample preparation procedures for histamine testing.
• 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 procedures in your HACCP plan for "Canned Sardine and Mackerel" are inappropriate. Specifically;
o Your corrective action listed at the "Storage of fresh fish in cold room" CCP states "Adjust the cold room temperature". However, adjusting the temperature will not mitigate any scombrotoxin (histamine) that was permitted to form during a period of time-temperature abuse when the critical limit was exceeded. In addition, the corrective action does not address the disposition of potentially adulterated product and preventing that product from entering commerce.
o The corrective action procedures listed at the "Reception at the seaport" or "Reception" CCP's do not ensure that the cause of the critical limit deviations will be corrected.
In addition, there are many processing steps in your operation where fish are removed from cold storage until product in seamed cans enters the retorts. Your firm needs to ensure that the time-temperature exposure during this cumulative period is properly controlled to prevent the formation of scombrotoxin (histamine) or other heat stable toxins, such as from Staphylococcus aureus.
For more information on the hazard of scombrotoxin (histamine) formation, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition. Chapter 7, found at www.fda.gov.
You should respond to us 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, including documentation such as copies of any revised HACCP plans, at least five (5) product days worth of HACCP and sanitation monitoring records to demonstrate that you have implemented the revised plan, any verification records, and other useful information that would assist us in evaluating your corrections. In addition, we would like you to submit the following:
• Copies of the boat records, as well as a description of the entry of observations on boat records, a description of the type of harvest vessels used in the operation and onboard practices as they relate to your revised HACCP plan which lists "Visual reviews of boat record documents" for the "Time of death and time of icing" as monitoring procedures;
• An explanation of how your firm determines each "lot" of product to ensure that a lot pertains to specific lots of fish from individual vessels;
• A clarification that the term "reorient" in your HACCP plan always means to divert product to other markets, and if so, how you ensure that the compromised product does not enter into the U.S.; and,
• A description of your thawing process for your frozen seafood, which is used when fresh seafood is not available, and a revised HACCP plan with an additional separate CCP for the thawing procedure (when applicable).
If you cannot complete all corrections before the 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 action to refuse admission of your canned sardine 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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA's laws and regulations. DWPE information is conveyed in FDA's Import Alerts. 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: http://www.accessdata.fda.gov/cms_ia/importalert_25.html.
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, the Seafood HACCP regulations, the Low-Acid Canned Food regulations (21 CFR 108 and 113), 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: Robyn Jones, 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. Jones by phone at (301) 436-2575 or via email at Robyn.Jones@fda.hhs.gov.
Sincerely,
/S/
Roberta Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
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