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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Laomerica Seafood, Inc. 01-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  New Orleans District
297 Plus Park Boulevard
Nashville, TN 37217
Telephone: 615-781-5380
FAX: 615-781-5391



October 28, 2005

WARNING LETTER NO. 2006-NOL-02

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Ms. Somxay Vongsakhamphouy, Owner
Laomerica Seafood Inc.
14085 Shell Belt Road
Bayou La Batre, Alabama 36509

Dear Ms. Vongsakhamphouy:

On August 22 - 26, 2005, a United States Food and Drug Administration (FDA) investigator inspected your ready-to-eat crabmeat processing facility, located at 14085 Shell Belt Road, Bayou La Batre, Alabama. We found serious deviations from the Seafood Hazard Analysis Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 2.1 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 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, Section 342(a)(4). You may find the Act and the Seafood HACCP regulations through links in FDA's Internet home page at
http://www.fda.gov. Accordingly, your ready-to-eat 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.

Our investigator collected samples of your cooked lump crabmeat under your label. The samples subsequently were analyzed for the presence of microorganisms. You should be aware Escherichia coli (E. coli) was recovered from one sample, collected on August 22, 2005, of the cooked, ready-to-eat lump crabmeat. You already may have received a letter from our Southeast Regional Laboratory in Atlanta, Georgia notifying you of the same. The presence of E. coli causes your crabmeat to be in violation of Section 402(a)(3) of the Act.

E. coli is part of the normal intestinal flora of humans or other primates. The presence of E. coli in your crabmeat is an indication of fecal contamination. Some strains of E. coli cause food-borne bacterial illness, such as gastroenteritis, which can be a serious illness for some people, especially the elderly, newborns, and those with weakened immune systems . Food processors and handlers should take all precautions necessary to reduce the risk of contamination and to keep food safe from E. coli. We strongly recommend you determine the cause(s) of this problem and take corrective action as soon as possible.

The deviations are as follows:

1. You must take corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Sections 123.7(b) and (c) require a corrective action to ensure no product enters commerce, which is either injurious to health or is otherwise adulterated as a result of the deviation and the cause of the deviation is corrected. However, your firm did not take a corrective action to control pathogen survival when you failed to cook the crabs for at least 15 minutes on the following : Cook 5 on August 21, 2005 ; Cook 3 on May 4, 2005 ; Cook 2 on August 20, 2004; Cooks 2 and 5 on July 27, 2004; Cook 4 on July 23, 2004; and, Cook 1 on July 17, 2004.

2. You must implement the record keeping system you listed in your HACCP plan, to comply with 21 CFR 123 .6(b):

a. You failed to record the internal crabmeat temperature at the picking and packing critical control points to control pathogen growth and toxin formation, as listed in your HACCP plan for fresh, picked crabmeat.

b. You failed to record cooler thermometer calibration procedures.

c. You failed to record the actual time during which you completed crab cooking operations. The time recorded on the cooking logs was entered at the start of the operations and is the projected time the operation is to be completed.

3. You must verify your HACCP plan for fresh, picked crabmeat is adequate to control food safety hazards reasonably likely to occur and the plan is being implemented effectively, to comply with 21 CFR 123.8(a). However, your firm failed to verify the HACCP plan is being implemented effectively. The thermometer you use to monitor the temperature of the cooler holding in-process crabmeat was not calibrated properly. A side-by-side comparison of your cooler thermometer with-an FDA thermometer revealed your thermometer registered 50°F, and the FDA thermometer registered 40°F. Because your thermometer was recording a temperature 10 degrees higher than the actual temperature, you necessarily would not know when you had met your critical limit of the cooler at or below 40°F at the backed crab cooling and finished product storage CCPs.

4. You must monitor adequately sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor sanitation conditions in the following areas with sufficient frequency to ensure control as evidenced by:

a. Prevention of cross contamination [21 CFR 123.11 (b)(3)]. Employees working in direct contact with food and food contact surfaces did not take precautions necessary to protect against cross-contamination with insanitary objects.

i. Employees handled non-sanitized objects and then cooked crabs without washing or sanitizing their hands. For example, an employee killed a fly with her hands and then resumed picking crabmeat without washing or sanitizing her hands. An employee handled a dirty plastic curtain, water hoses, brooms, and knobs, then spread ice over cooked crabs on the picking table without washing or sanitizing his hands. Two employees handled unsanitized trash cans, then handled crabs during backing operations without washing or sanitizing their hands.

ii. Employees failed to wear appropriate hair restraints in an effective manner. Specifically, employees were seen working in and around the crab picking and packing operations without adequate hair restraints, A similar deviation was brought to your attention in our letter to you on August 11, 2004.

iii . Employees failed to remove all unsecured jewelry that might fall into food. For example, on August 23, 2005, an employee was wearing dangling earrings while picking crabmeat.

b. Condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)]. On August 22 and 23, 2005, crab processing utensils were not cleaned properly prior to reuse. The investigator observed employees using knives with etched handles encrusted with black residues during crab picking operations.

c. Exclusion of Pests [21 CFR 123.11(b)(8)]. You have not taken effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests.

i. On August 22 and 23, 2005, flies were observed landing on raw and cooked crabs and on the table in the backing room. In addition, flying insects were seen on the ceilings, floors, and a light fixture in the backing/cooking room during evening cooking/backing operations. The presence of flying insects in your operation was brought to your attention
in our letter to you dated August 11, 2004.

d. Protection of Food from Contaminants [21 CFR 123.11(b)(5)]. You failed to protect food, food packaging material, and food contact surfaces from adulteration with physical and biological contaminants.

i. Two lights above the crab picking table were not covered throughout crabmeat picking operations.

ii. Employees stored baskets of opened product containers and closures under the packing and weighing table. Condensation was observed to form and drip onto the containers which were used to hold crabmeat without washing or sanitizing them. In addition, condensation was observed to form and drip from the ceiling above the backing table on August 23, 2005, onto cooked backed crabs.

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 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.

Your reply should be directed to Mark W. Rivero; Compliance Officer, at 299 Plus Park Blvd, Nashville, TN 37217. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (615) 695-4654, ext. 113.

Sincerely,
/s/

H. Tyler Thornburg
District Director
New Orleans District