Warehouse Food Group, LLC 27-Jul-04

July 27, 2004

WARNING LETTER NO. 2004-NOL-30

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Steven Loga, Owner
Warehouse Food Group, LLC
11579 Cedar Park Avenue
Baton Rouge, Louisiana 70809-4253

Dear Mr. Loga:

On May 3, 6, and 7, 2004, the United States Food and Drug Administration (FDA) inspected your seafood processing facility, Warehouse Food Group, LLC, located at 11579 Cedar Park Avenue, Baton Rouge, Louisiana. We found that you have serious deviations from the Seafood Hazard Analysis Critical Control Point (HACCP) regulations, 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 that complies 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), 21 U.S.C. 342(a)(4). Accordingly, your fish and crabmeat products are adulterated, in that 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 regulations through links in FDA’s Internet home page at http://www.fda.gov.

The following deviations were observed during the inspection:

• Pursuant to 21 CFR 123.6(a), your firm is required to conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and to identify the preventive measures that your firm will apply to control those hazards. Your firm also, pursuant to 21 CFR 123.6(b) and (c), must have and implement a written HAACP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur and thus must be controlled for each fishery product. A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” Your firm, however, does not have a HACCP plan for frozen, vacuum-packaged fish to control the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation.

We particularly are concerned with your failure to identify and to implement controls for C. botulinum toxin formation in a HACCP plan for frozen, vacuum-packaged fish. To prevent toxin production by C. botulinum, fish must be maintained in a frozen condition until immediately before use by the consumer. Also, it should be labeled with adequate storage instructions such as “Important, keep frozen until used, thaw under refrigeration immediately before use.” Thus, your HACCP plan for frozen, vacuum-packaged fish needs to identify “Labeling” as a critical control point. A critical control point is defined in 21CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels,”

Please note, in place of identifying “Labeling” as a critical control point in your HACCP plan, you have another option for frozen, vacuum-packaged product under HACCP. The product description on your HACCP plan may identify the product as “vacuum-packaged frozen fish, labeled ‘Important, keep frozen until used, thaw under refrigeration immediately before use’.”

• Pursuant to 21 CFR 123.6(a) and (c)(2), your firm must have a HACCP plan that, at a minimum, lists the critical control points for each of the identified food safety hazards. However, your firm’s HACCP plan for scombrotoxin-producing species does not list the critical control point of thawing for controlling the food safety hazard of histamine formation. Also, your firm’s HACCP plan for refrigerated, vacuum-packaged, fresh fish is inadequate as it does not list the critical control points of finished product storage and distribution for controlling the food safety hazard of C. botulinum toxin formation.
  
• Pursuant to 21 CFR 123.6(b) and (c)(4), your firm must implement the monitoring procedures in your firm’s HACCP plan for each of the critical control points to ensure compliance with the critical limits. 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 did not follow the monitoring procedure of time and temperature at the freezing critical control point to control the parasite hazard listed in your HACCP plan for Sushi Fish. Also, your firm did not follow the monitoring procedure for determining crabmeat temperature at the Receiving critical control point to control the pathogen growth hazard listed in your HACCP plan for Pasteurized Crabmeat. In addition, your firm did not follow the cooler temperature monitoring procedure at the Storage critical control point to control the pathogen growth hazard listed in your HACCP plan for Pasteurized Crabmeat.
  
• Pursuant to 21 CFR 123.6(c)(7), your firm’s HAACP plan must provide a recordkeeping system that documents the monitoring of the critical control points. The records, moreover, must contain the actual values and observations obtained during monitoring. However, your firm did not record monitoring observations at the Receiving nor Storage critical control points to control the pathogen growth listed in your HACCP plan for Pasteurized Crabmeat.
  
• Pursuant to 21 CFR 123.11 (b), your firm must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in the Current Good Manufacturing Practice requirements for foods, 21 CFR 110, that are appropriate to your plant and the food that your firm processes. The conditions and practices your firm is to monitor include the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, and maintenance of hand sanitizing facilities, 21 CFR 123.11 (b)(3) and (4). However, your firm did not monitor prevention of crosscontamination or maintenance of hand sanitizing facilities with sufficient frequency to ensure control as evidenced by:

  a. During the processing of salmon on May 5, 2004, two sanitizing stations tested contained less than 10 ppm of the chlorine sanitizing agent. An employee’s gloved hand came into contact with an insanitary object. The gloved hand was dipped into this underactive sanitizing solution, and then came into direct contact with fish and the processing table.

  b. Two unsanitary personal drinking cups were stored inside the vacuum-packaging machine in the processing area.

On April 28, 2004, FDA collected a sample of grouper fillets, cut from [redacted] of whole grouper, as sample number 249646. As you are aware, FDA analysis found this product to be decomposed. On May 3, 2004, an FDA investigator witnessed your voluntary destruction of approximately [redacted] of grouper fillets. [redacted] Please inform us of what steps your firm took to retrieve the decomposed fish distributed in commercial channels.

We may take further action if you do not correct these violations promptly. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

We are aware that Mr. Alan P. Porche, Manager, made verbal commitments to correct the deviations during the inspection. However, we request that you notify this office in writing, within 15 working days from your receipt of this letter, of the specific steps you have taken to correct these deviations. You should include in your response documentation, such as your HACCP plans and monitoring records or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Current Good Manufacturing Practice regulations, 21 CFR 110. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply 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.

Sincerely,

/s/

H. Tyler Thornburg
District Director
New Orleans District

Enclosure: Form FDA 483