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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Hanover Foods Corporation 10/21/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410)779-5454 FAX: (410) 779-5703

FEI (b)(4)

WARNING LETTER

CMS# (b)(4)

October 21, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. John A. Warhime, CEO/Chairman
Hanover Foods Corporation
P.O. Box 334
Hanover, Pennsylvania 17331

Dear Mr. Warhime:

The Food and Drug Administration (FDA) conducted an inspection of your produce manufacturing facility, located at 502 Factory Lane, Hanover, Maryland from April 6 to April 30, 2009 and from May 11 to May 27, 2010.  During the inspection, FDA collected a number of samples. Laboratory analyses of these samples found the presence of the pathogen Listeria monocytogenes (L. mono) in environmental and in-line samples.  In addition, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These observations and the results of the laboratory analysis cause the foods manufactured at your facility to be adulterated under 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act), in that they were 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 FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

During the inspection, FDA collected samples of in-line sliced mushrooms, and environmental swabs and sponges taken from throughout your processing facility, including the Individually Quick Frozen (IQF) room. Laboratory analysis of the samples confirmed the presence of L. mono in a sliced mushroom in-line sample and in an environmental sample from a food contact surface.  The finding of L. mono in a sliced mushroom in-line sample, and on food contact surfaces in your facility indicates a high risk of finished product contamination.

L. mono is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility.  L. mono can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Listeriosis is an atypical foodborne illness of major public health concern because of the severity of the disease, a high case-fatality rate, a long incubation and a predilection for individuals with underlying conditions.

Our investigators documented a number of significant objectionable conditions relating to your facility’s compliance with the CGMP regulations.  Significant deviations observed during the inspection include:

1. Your firm failed to take effective measures to protect finished food from contamination by ingredients or refuse, and failed to protect food transported by conveyor against contamination as required by 21 CFR 110.80(b)(6). Specifically, the following was observed during the inspection:

A. Ready-to-eat mushrooms were observed spilling from the hopper affixed to the conveyer belt in the IQF room onto an electrical panel accumulated with old food debris.  After the mushrooms spilled onto the electrical panel accumulated with old food debris they bounced into a 40lb box containing ready-to-eat mushrooms.

B. Accumulated mushroom debris was observed caught between the conveyer belt and conveyer belt wheel. The accumulated mushroom debris was observed being sprinkled into open boxes containing ready-to-eat mushrooms in the IQF room.

C. Defrosted mushroom debris was observed accumulated on the following pieces of equipment during operation and coming in contact with the rotating conveyer belt carrying ready-to-eat mushrooms to be packed: 

  a) Cross beam beneath the magnet as mushrooms exit from the IQF freezer.
  b) Scraper located beneath the magnet as mushrooms exit from the IQF freezer.
  c) Metal guide affixed to magnet as mushrooms exit from the IQF freezer.

2. Your firm failed to take effective measures to protect against the inclusion of metal or other extraneous material in food as required by 21 CFR 110.80(b)(8). Specifically, an accumulation of rust was observed on multiple bolts affixed to a grow rack containing wheat grass in the “Green Sprout Grow Room.”  The bolts were observed to be dripping water that accumulated on them from the grow rack's watering system.  The rusty bolts were located directly over multiple pans containing in-process (growing) wheat grass.

3. Your firm failed construct your facility in such a manner that drip or condensate from fixtures 

does not contaminate food as required by 21 CFR 110.20(b)(4). Specifically, two 55 gallon drums that contained ready-to-eat alfalfa sprouts were observed stored uncovered under a water hose reel that was affixed to the wall of the “Sprout Washroom.” The water hose reel was accumulated with water and water droplets were observed dripping into the drums that contained uncovered ready-to-eat alfalfa sprouts.

4. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the following was observed during the inspection:

A. The receiving door located on the western wall of the “Dry Warehouse” had three gaps leading to the exterior of the firm.

B. The northern wall of the “Green Bean Room” had a gap which led to the exterior of the firm.

C. The exit door on the southern wall of the “Green Bean Room” had a gap which led to the exterior of the firm.

We have reviewed your June 9, 2010 response letter to the FDA-483 from Bridget Dadds, QC Management. Although your letter states that a number of corrective actions have been completed, the actions outlined in your response letter have not fully addressed all our concerns.  Please submit documentation which shows completion of corrections (i.e., revised SSOPs, photographs or receipts that verify equipment or other structural modifications, etc.) and steps you have taken to prevent contamination of finished products with L. mono. The adequacy and implementation of your corrective actions and will be assessed during our next inspection.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, and the CGMP regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions since your June 2010 correspondence, including any further specific steps that you have taken to correct violations. 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 violations.

Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Branch Director at the address above.  If you have questions regarding any issues in this letter, please contact Mr. Pack at (410) 779-5417.
Sincerely,
/s/
Evelyn Bonnin
District Director

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