Inspections, Compliance, Enforcement, and Criminal Investigations
Crabs, LLC 17-Nov-06
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
November 17, 2006
WARNING LETTER 2007-NOL-06
Mr. Dennis J. Landry, President/Co-Owner
246 South Main Street
Lockport, Louisiana 70374-3618
Dear Mr. Landry:
On August 9, 10 and 16, 2006, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 246 South Main Street, Lockport, Louisiana. We found you have serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and the Current Good Manufacturing Practices (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Parts 123 and 110 (21 CFR 123 & 110), respectively. 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 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)]. You may find the Act and the seafood HACCP regulation through links in FDA's Internet 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 were as follows:
1. You must implement the record keeping system you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the backing critical control point to control pathogen growth and toxin formation as listed in your HACCP plan for blue crabmeat.
2. You must have a HACCP plan which, at a minimum, lists the critical limits which must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for blue crabmeat lists a critical limit, [redacted], at the Picking and Packing critical control point (CCP) which is not adequate to control pathogen growth and toxin formation. Specifically, the critical limit does not provide the time/frequency for monitoring the presence of ice under which the crabmeat may be exposed during picking operations.
In addition, the critical limit in this HACCP plan at the "Backing" CCP listed as '[redacted] is inadequate to control pathogen growth and toxin formation. The Hazard Guide recommends cooling rates for cooked crabs achieve cool down from 140° F to 70° F within 2 hours; and from 70° F to 40° F within 4 additional hours.
3. Your firm did not adequately monitor the prevention of cross-contamination from insanitary objects to food, as required by 21 CFR 123.11(b)(3). For example:
a. The ice, which comes into direct contact with cooked crabs and crab parts, and used to cool/refrigerate cooked crabs, was observed stored directly on the floor and near exposed insulation materials of the cooler wall.
b. Employees working in direct contact with food and food-contact surfaces did not take necessary precautions to protect against contamination. These actions include:
i. An employee repeatedly contacted the residue-stained, wooden and metal cooler door handles with her bare hands and then contacted cooked crabs on the picking table and totes filled with cooked crabs without cleaning or sanitizing her hands;
ii. An employee picking crabs was observed touching her nose and face then picking crabmeat without washing or sanitizing her hands; and,
iii. An employee backing crabs was observed touching her nose and face then picking crabmeat without washing or sanitizing her hands.
4. Your firm did not adequately monitor the protection of food, food packaging material, and food-contact surfaces from adulteration with condensate and other biological or physical contaminants, as required by 21 CFR 123.11(b)(5). Specifically, your facility is not constructed in a manner to prevent condensate from contaminating food, food-contact surfaces, and food packaging materials. On August 10, 2006, condensate dripped from the ceiling of the walk-in cooler onto ice used to refrigerate cooked crabs and crab parts.
5. You did not monitor the exclusion of pests from the food plant, as required by 21 CFR 123.11(b)(8). Specifically, you have not taken adequate measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests. For example, on August 10, 2006:
a. One fly was observed on a perforated basket used to hold cooked crab claws during crabmeat picking operations;
b. Four live flies were in the picking room approximately three feet from cooked crabs and crab parts;
c. At least fifty dead flies were observed throughout various locations in the picking room, including window sills, in light fixtures above picking tables, and in a spider's web in the packing room; and,
d. Ten dead flies were on the southeast wall, two feet above the backing table during backing operations.
Furthermore, you have not provided adequate screening or other protection against pests as evidenced by the following:
a. The screen on the south wall of the cook room has a 1" x 1 .5" tear permitting entry of insects directly from the exterior of the plant; and,
b. The fan in the cook room does not contain a screen and opens directly to the exterior of the building.
6. Your firm did not adequately monitor the conditions and cleanliness of food-contact surfaces, as required by 21 CFR 123.11(b)(2). Your firm's food processing equipment is not maintained in a sanitary condition to prevent food from becoming adulterated. For example:
a. Black residues were observed on shovels used to scoop ice onto cooked crabs;
b. The electric hoist control was encrusted with brown residues which came in contact with cooked crabs;
c. Black residues were observed in the rough, welded seams of the backing table;
d. The knives used by three employees to pick crabmeat were observed to have etched handles which contained brown residues;
c. The welded seams of two aluminum rakes, used to transfer cooked crabs on the backing table, contained brown and black residues; and,
f. Five perforated baskets, used to store cooked crabs and crab parts, were stained with brown and green residues.
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. We are aware 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 sanitation 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 and CGMP 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, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
H. Tyle Thornburg
New Orleans District
Enclosure: Form FDA 483