Inspections, Compliance, Enforcement, and Criminal Investigations
Mike's Seafood 02-Aug-05
Department of Health and Human Services
Public Health Service
New Orleans District
August 2, 2005
WARNING LETTER NO. 2005-NOL-31
Mrs. Thanh Thi Le, Co-Owner
Mr. Mike Pham, Co-Owner
516 South Lewis Street
New Iberia, LA 70560-4819
Dear Mrs. Le and Mr. Pham:
On May 25 -27, 2005, an investigator from the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 516 South Lewis Street, New Iberia, Louisiana. We found you have serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 342(a)(4). Accordingly, your crabmeat and crawfish tail meat are adulterated, as they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA's Internet home page at http://www.fda.gov.
Deviations found during the inspection include, but are not limited to, the following:
You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you produce, to determine whether there are food safety hazards reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for vacuum-packed crabmeat or for vacuum-packed crawfish tail meat to control the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation. C. botulinum toxin formation would not be reasonably likely to occur and thus would not need to be included in your HACCP plan if actions such as one of the following were taken:
a. The product is sealed in packaging material having an oxygen transmission rate of more than 10,000 cubic centimeters per square meter per 24-hour period of time (10,000 cc/m2/l24hr at 24°C and 1 atm); or,
b. The product bears a validated time temperature integrator (TTI), including instructions as to its interpretation, as a monitoring device to control C. botulinum toxin formation on each retail or consumer package. A TTI is a device which provides a clear indication to the retailer/consumer, by color change or other means, the product may have been exposed to a time and temperature combination and could result in an unsafe product; or,
c. The product is frozen immediately after processing, maintained frozen throughout distribution, and labeled prominently with instructions to hold frozen and to thaw under refrigeration immediately before use (e.g. "Important, Keep Frozen, Thaw Under Refrigeration Immediately Before Use").
Please note, in place of identifying "Labeling" as a critical control point in your HACCP plans, you have another option for frozen, vacuum-packaged product: The product description on your HACCP plans may identify the products as "vacuum-packed frozen crabmeat, labeled `Important, keep frozen until used, thaw under refrigeration immediately before use'," or as "vacuum-packed frozen crawfish tail meat, labeled `Important, keep frozen until used, thaw under refrigeration immediately before use'."
You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with the conditions and practices in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor prevention of cross contamination from raw product to cooked product and exclusion of pests from the food plant with sufficient frequency to ensure control. This was evidenced on May 25, 2005, by two crates of live crabs stored in the cooler directly next to several crates of cooked crabs. The separation was not enough for an employee to remove the cooked crabs without their hands contacting the crates of live crabs. Also, on May 25 and 26, 2005, live flies were observed in the crawfish and crabmeat picking/packing rooms.
You must maintain sanitation control records which, at minimum, document monitoring of your processing conditions and practices and corrections, to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for prevention of cross-contamination from insanitary objects required for the processing of picked crabmeat.
We also note your crabmeat and crawfish tail meat products are misbranded within the meaning of Section 403(q)(1) of the Act, as their labels fail to bear nutritional labeling, as required by 21 CFR 101.9, and the products are not exempt from this requirement.
We may take further action if you do not promptly correct the violations described in this letter. These actions may include seizing your products and/or enjoining your firm from operating.
We recognize at the close of inspection you made a verbal commitment to correct the observed deviations. However, you should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps taken to correct the noted violations. You should include in your response copies of documentation, such as your HACCP plan, daily sanitation report, corrected labels for crabmeat and crawfish tail meat, and other useful information to assist us in evaluating your corrections. If corrective action cannot completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
This letter may not list all the deviations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and FDA regulations. You also have a direct responsibility to prevent further violations of the Act and all applicable regulations. Your reply should be directed to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
Carol S. Sanchez
Acting District Director
New Orleans District