B & F Fish Market Llc 10/26/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New Orleans District 404 BNA Drive Building 200 – Suite 500 Nashville, TN 37217 Telephone: (615) 366-7801       FAX:   (615) 366-7802

October 26, 2011

WARNING LETTER NO. 2012-NOL-02

UNITED PARCEL SERVICE

Delivery Signature Requested

Bobby J. Bassett, Co-Owner

Roy G. Forsha, Co-Owner

B & F Fish Market, LLC

4042 Highway 412 East

Parsons, Tennessee 38363-3613

Dear Messers. Bassett and Forsha:

On June 21 and 23, 2011, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, B & F Fish Market, LLC, located at 4042 Highway 412 East, Parsons, Tennessee. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 110. 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 21 CFR 123, renders the fish or 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 (21 USC), Section 342(a)(4). Accordingly, your seafood products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s Internet home page at www.fda.gov.

Significant violations were listed on a FORM FDA 483, Inspectional Observations, issued to Mr. Bassett on June 23, 2011, and include, but are not limited to, the following:

1.      You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). During the inspection, product residues were observed on many food contact surfaces; employee processing and hand-washing areas; baskets which held processed fish; and, items in the cooler and ice storage area, handled by processing employees.

2.      Failure to maintain building, fixtures, and physical facilities in a sanitary condition and sufficient repair to prevent food from becoming adulterated [21 CFR 110.35(a)]. 

• The refrigeration unit in the ice room is partially detached from the ceiling, dangling from the ceiling, and contacting the ice used on dressed fish.  The walls, ceiling, and interior cooler door of the walk-in cooler had accumulations of product residues.
• The ceiling of the cooler is corroded which prevents effective cleaning and sanitizing of the surface.
• Floors of the cooler, processing room and adjacent room with the three compartment sink had accumulations of product residues and areas of algae or mold growth.

3.   Failure to maintain the plant and grounds in a sanitary manner to prevent product contamination [21 CFR 110.20(a)]. For example, there was a poorly drained, unpaved walkway from the live well building directly into processing area; and, an accumulation of trash and debris next to buildings which can provide a harborage for pests.

4.   Failure to have suitable plant structures [21 CFR 110.20(b)(4)]. For example, the floors of the processing area are not maintained in a manner that allows them to be adequately cleaned. Floor surfaces are eroded to a point where they are pebbled and pitted which precludes effective cleaning and sanitizing. There is an exposed and damaged wood doorway between processing room and walk-in cooler and exposed insulation on the outside of the ice room next to thermometer.

5    Failure to clean all food contact surfaces as frequently as necessary to protect against contamination of the food [21CFR110.35(d)(2)]. For example, there were accumulations of product residue and black mold observed on the interior and exterior surfaces of a green bin used to store skinned catfish. The investigator observed a build up of dried fish residue on wires and crevices of a wire basket used to hold fish prior to weighing.

6.  Failure to maintain all non-food contact surfaces of equipment used in the operation of food plant to be cleaned frequently as necessary to protect against contamination of food [21 CFR 110.35(d)(3)]. For example, the handle of the ice shovel is dirty with an accumulation of product residue. There was an accumulation of filth and product residue on underside surfaces of processing area sink and the floor and pipes under sink.  The band saw used for heading catfish had accumulations of product residue along the sides of the machine and under the work surface, in addition to areas of corrosion which prevent effective cleaning and sanitizing.

7.  Failure to maintain the plant’s restroom in a clean and sanitary manner [21 CFR 110.37(d)]. For example, floors, pipes, and toilet had visible accumulation of a film.

8. Failure to minimize the development of odor, minimize the potential for waste to become a pest attractant or harborage area, and the protection against the contamination of food products [21 CFR 110.37(f)]. For example, fish offal was stored in open, dirty plastic barrels in the cooler with finished products. The barrels show an accumulation of filth on the interiors and exteriors. The walls adjacent to barrels are covered with splash from the offal stored in the barrels.

9.  Failure to handle work-in-process in a manner which protects against product contamination [21 CFR 110.80(b)(5)]. For example, perforated plastic baskets and wire baskets used to hold skinned catfish were observed in direct contact with the wet processing room floor. Baskets have openings on the bottom which allow fish to come in direct contact with the floor or water on the floor.  A green plastic bin covered with a piece of white paper, containing skinned catfish was stored directly on the floor of the cooler.  Perforated plastic baskets of skinned catfish were placed directly next to dirty basket used to hold fish offal.

FDA acknowledges the corrective actions you have voluntarily taken, such as signing your HACCP plan; cleaning the facility; and, obtaining signatures of fish suppliers on the supplier guarantee.

We may take further action if you do not promptly correct all of the noted violations. For instance, legal actions may include product seizure or injunction. You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations. You should include in your response documentation such as HACCP and verification records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulations (21 CFR 123) and the CGMP regulation (21 CFR 110). You 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: Kari L. Batey, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.

Sincerely, 

/S/ 

Patricia K. Schafer

District Director

New Orleans District

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