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Public Health Service |
New Orleans District Telephone: 615-366-7801 |
September 19, 2008
WARNING LETTER NO. 2008-NOL-22
FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED
LaQuita J. Meek, Owner
Meek's Seafood, Inc.
105 East Avenue J
Larose, Louisiana 70373
Dear Ms. Meek:
On June 4-6 and 10, 2008, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, located at 105 East Avenue J, Larose, Louisiana. During the inspection, our investigator documented serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan to comply 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 United States Code, Section 342(a)(4)]. Accordingly, your ready-to-eat crabmeat products are adulterated because 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 on FDA's Internet home page at www.fda.gov.
On June 10, 2008, our investigator documented significant violations of seafood HACCP and CGMP regulations, which were discussed with you. The violations include, but are not limited to, the following:
1. You must implement the monitoring procedures listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures at the cooking and backed crabs critical control points to control pathogen survival and/or pathogen growth and toxin formation in your HACCP plan for "Blue Crab/Ready-to-eat Fresh Crabmeat." Specifically, you did not monitor or record:
•Cook water temperatures at the "Cooking" critical control point (CCP);
• Cool-down temperatures of cooked crabs at the "Backing" CCP (i.e., following the cooking process);
• Internal temperatures at the "Backed Crab" (refrigerated storage) CCP;
• Length of time products were exposed to unrefrigerated temperatures at the "Picking" and "Packing" CCPs; and,• Time in cooler at the "Backing" CCP.
2. 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 which, at a minimum, lists the CCPs,
to comply with 21 CFR 123.6(a) and (c)(2). A CCP 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 Blue Crab/Ready-to-eat Fresh Crabmeat does not list a critical
control point for the refrigerated storage of unpicked backed crabs and crab claws to control
the food safety hazard of pathogen growth and toxin formation. FDA recommends implementing a method of continuously monitoring cooler temperatures when products are stored, un-iced, for significant time periods.
3. 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 plans listed in the HACCP plan for Blue Crab/Ready-to-eat Fresh Crabmeat at the "Cooking", "Backing", "Backed Crab", "Picking", "Packing" and "Finished Product Cooler" critical control points to control pathogen survival and/or pathogen growth and toxin formation are inappropriate. To comply with 21 CFR 123.7(b), corrective action plans must ensure: no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviations; and, the cause of the deviation is corrected. Your corrective actions of, "Segregate hold for evaluation" at the "Cooking"
CCP; "Hold and evaluate based on total time exposed to unrefrigerated conditions" at the "Backing" CCP; "Move to other cooler" at the "Backed Crabs" CCP; "Move to cooler" at the "Picking" and "Packing" CCPs ; and, "Move to another cooler and/or add ice" at the "Finished Product Cooler" CCP ensure neither requirement. In addition to the actions you propose, your corrective action plans should include criteria for the rejection or destruction of products and how you will address the cause of the deviations.
4. You must take an appropriate corrective action when a deviation from a critical limit occurs,
to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to
control the hazard of pathogen survival when your process for ready-to-eat crabmeat deviated
from your critical limit at the "Cooking" CCP. On June 5, 2008, our investigator observed a
batch of crabs was cooked for only five minutes. Your HACCP plan requires a [redacted] minute
cook. Our investigator did not observe your firm taking any corrective action in response to
this; nor, did your cook log document any corrective action taken in response.
5. You must have sanitation control records which document monitoring and corrections in order to comply with 21 CFR 123.11 (c). However, your firm does not maintain sanitation monitoring records for the safety of water, including ice, which comes in contact with food or food contact surfaces, required for the processing of your ready-to-eat crabmeat products.
The above deficiencies should not be construed as an all-inclusive list of violations which may exist at your facility. It is your responsibility to ensure your facility is operating in full compliance with the Act, the seafood HACCP regulation (21 CFR 123), and the CGMP regulation (21 CFR 110).
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
Additionally, you must verify your HACCP plan is adequate to control the food safety hazards reasonably likely to occur, to comply with 21 CFR 123 .8(a). Your HACCP plan for Blue Crab/Ready-to-eat Fresh Crabmeat does not list verification procedures or frequencies that have been developed to ensure the HACCP plan is being effectively implemented. Your HACCP plan fails to list verification procedures to ensure weekly records review, implementation of corrective actions, the adequacy of your process (e.g., internal temperature checks), and calibration of monitoring equipment.
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as HACCP and monitoring records and other useful information, to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 219-8818, extension 104.
Sincerely,
/S/
H. Tyler Thornburg
District Director
New Orleans District
Enclosure: Form FDA 483, dated June 10, 2008
Department
of Health and Human Services