Inspections, Compliance, Enforcement, and Criminal Investigations
Lynn's Seafood 14-Apr-05
Department of Health and Human Services
Public Health Service
New Orleans District
April 14, 2005
WARNING LETTER NO. 2005-NOL-16
Mr. Trai N. Vo, Owner
217A Graveline Road
Gautier, Mississippi 39553-6317
Dear Mr. Vo:
On February 15-17, 22-23, 25, and March 1, 2005, United States Food and Drug Administration (FDA) investigators inspected your crabmeat processing facility, located at 217A Graveline Road, Gautier, Mississippi . We found serious deviations from FDA's Seafood Hazard Analysis Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations (CFR), Parts 110 and 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 requirements of this part renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), Title 21, United States Code (USC), Section 342(a)(4). You may find the Act and the Seafood HACCP regulations through links in FDA's home page at http://www.fda.gov. Accordingly, your crabmeat is adulterated, since it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
The deviations are as follows:
1 . You failed to conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and have a written HACCP plan for cooked, ready-to-eat crabmeat for controlling the food safety hazards of pathogen growth and toxin formation, as required by 21 CFR 123.b(a) and (b).
2. You failed to monitor the exclusion of pests from the food plant, as required by 21 CFR 123.11(b)(8). This deviation further violates the requirements of 21 CFR 110.35(c) . Specifically, you have not taken adequate measures to exclude pests from processing areas and protect against the contamination of food on the premises by pests. For example, four live flies were observed on cooked crabs and crab contact surfaces in the picking and packing room. In addition, three live flies were observed landing on cooked crabs and crab contact surfaces in the cooking room.
3. You failed to adequately monitor the prevention of cross-contamination from insanitary objects to food, as required by 21 CFR 123.11(b)(3). This deviation further violates the requirements of 21 CFR 110.10(b) . Specifically, employees working in direct contact with food and food contact surfaces did not take necessary precautions to protect against contamination. This includes:
a. On February 15, 2005, four employees repeatedly contacted unsanitized, perforated baskets and processing room doors containing black residues and then resumed picking crabmeat without washing or sanitizing their hands or gloves;
b. Two employees conducting cooked crabmeat picking operations were observed wearing hair restraints that did not adequately restrain their hair while standing over open containers of cooked crabmeat; and,
c. Employees failed to remove unsecured jewelry or other unsanitized objects which could contact food. For example, on February 15, 2005, an employee's bracelet repeatedly contacted cooked crabs, crab contact surfaces, and crab parts.
4. You failed to adequately monitor the condition and cleanliness of food contact surfaces, as required by 21 CFR 123.11(b)(2). This deviation further violates the requirements of 21 CFR 110.40(a) since food processing equipment is not designed to allow adequate cleaning and to preclude the adulteration of food. For example, employees used etched-handled knives, with black residues in the grooves of the etchings, to crack crab claws. Similarly, you failed to maintain equipment, utensils, and finished food containers (including cooked crabmeat containers and lids, a backing table, a backed crab washing table, and crab rakes) in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1).
5. You failed to maintain sanitation control records documenting, at minimum, the monitoring and corrections of problems involving safety of water coming into contact with food or food contact surfaces; condition and cleanliness of food contact surfaces; prevention of cross-contamination; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with contaminants; proper labeling, storage, and use of toxic compounds; control of employee health conditions which could result in microbiological contamination of food, food packaging material, and food contact surfaces; and exclusion of pests from the facility, as required by 21 CFR 123.11(c) . Specifically, your firm did not complete sanitation control records for crab cooking/backing/picking operations conducted September 6, 2004 through February 18, 2005.
We may take further action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating. You made a verbal commitment to correct the observed deficiencies at the close of the inspection.
Please respond in writing within fifteen (15) working days from your receipt of this letter outlining the specific steps you are taking to correct these deviations. You should include in your response any documentation, such as your HACCP plan, copies of temperature monitoring records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter is not intended to be an all-inclusive list of the deviations at your facility . You are responsible for ensuring your processing plant operates in compliance with the Act, Seafood HACCP regulations, and Current Good Manufacturing Practice regulations (21 CFR 110). You also have a direct responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, New Orleans District, Attention: Mark W. Rivero, Compliance Officer, 6600 Plaza Drive, Suite 400, New Orleans, Louisiana 70127. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519.
H. Tyler Thornburg
New Orleans District