Inspections, Compliance, Enforcement, and Criminal Investigations
Harvest Time Seafood, Inc 23-Jun-06
Department of Health and Human Services
Public Health Service
New Orleans District
June 23, 2006
WARNING LETTER NO. 2006-NOL-10
Mr. Kevin E. Dartez, President/Co-Owner
Harvest Time Seafood, Inc.
208 West Elina Street
Abbeville, Louisiana 70510
Dear Mr. Dartez:
On April 25 - 27, and May 8, 2006, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 208 West Elina Street, Abbeville, 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, crawfish tail meat, crab cake, stuffed crabs, and stuffed crab fingers are adulterated, since those products 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.
The deviations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and you must have 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 crab cakes, stuffed crabs, and stuffed crab fingers to control the food safety hazards of Staphylococcus aureus and sulfites.
2. You must have a HACCP plan which, at a minimum, lists the critical limits that 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 plans list critical limits which do not adequately control the following hazards:
a. Your HACCP plan for vacuum-packaged crabmeat lists a critical limit at the package/label receiving critical control point (CCP) which is not adequate to control Clostridium botulinum growth and toxin formation. Specifically, the vacuum package label does not provide instructions to thaw under refrigeration.
b. Your HACCP plan for vacuum-packaged crawfish lists the critical limit of [redacted] at the packing CCP and [redacted] at the finished product storage CCP which are not adequate to control Clostridium botulinum growth and toxin formation.
3. You must implement the monitoring procedures you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures of assuring the label for the [redacted] statement at the packaging receiving CCP to control Clostridium botulinum growth and toxin formation, as listed in your HACCP plan for vacuum-packaged crawfish.
4. 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 April 25, 2006:
a. One fly was observed in a colander used to hold crabmeat during crabmeat picking operations;
b. One fly was observed on a plastic container cover near the north wall of the picking room during crabmeat picking operations;
c. One fly was observed on the backing table in the cooking room during crab cooking operations;
d. One fly was observed on a gray, plastic tote approximately three feet from a packing employee during crabmeat picking operations;
e. One fly was observed on the bottom of a plastic cup used for packing crabmeat during crabmeat picking operations; and,
f. One fly was observed on the window and one fly was observed on the door frame separating the picking and packing rooms during crab picking operations.
5. 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). Specifically, employees working in direct contact with food and food contact surfaces did not take necessary precautions to protect against contamination. These include:
a. Employees handling unsanitized objects and then cooked crabs without washing or sanitizing their hands. For example, employees touched ink pens, note pads, and dirty paper towels and then contacted open cups of finished product crabmeat without washing or sanitizing their hands;
b. Picking employees were observed repeatedly rubbing their gloved hands on their faces and resuming picking crabmeat without washing or sanitizing their gloved hands;
c. Employees were observed wearing green finger cots cut from rubber gloves while picking crabmeat;
d. An employee repeatedly contacted insanitary objects with his bare hands and then contacted totes filled with cooked crabs without cleaning or sanitizing his hands before touching the totes; and,
e. Two employees were observed chewing gum directly over finished product crabmeat during picking and packing operations.
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, on April 25, 2006, brown residue from previous operations was observed on a bowl and fork used for preparing stuffed crab fingers.
7. 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). In particular, your facility is not constructed in a manner to prevent condensate from contaminating food, food contact surfaces, and food packaging materials. On April 25 and 26, 2006, condensate dripped from the ceiling of the cooked/finished product walk-in cooler above totes of cooked/backed crabs and crab claws. In addition, on April 26, 2006, condensate was observed on two air vents above picking tables in the crabmeat picking operations.
The following deviation, not cited on the FDA-483, was discovered upon further review of the inspectional evidence collected:
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). However, your firm's HACCP plan for vacuum-packaged crawfish lists a critical limit at the package/label receiving CCP which is not adequate to control Clostridium botulinum growth and toxin formation. Specifically, the vacuum-package labels for crawfish do not provide instructions to thaw under refrigeration.
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.
Carol S. Sanchez
Acting District Director
New Orleans District