| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human ServicesJuly 22, 2011
WARNING LETTER NO. 2011-NOL-18
UNITED PARCEL SERVICE
Delivery Signature Requested
William B. Sansom, CEO
The H.T. Hackney Company
306 Fidelity Building
Knoxville, Tennessee 37902
Dear Mr. Sansom:
We inspected your seafood processing facility, located at 5828 Ooltewah-Ringgold Road, Ooltewah, Tennessee, on February 28, and March 1-3, 2011. 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 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 Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) [21 United States Code (USC) 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). Accordingly, your Tuna Salad sandwich product is adulterated, because it has been prepared, packed, or held under insanitary conditions whereby it 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 in FDA's Internet home page at www.fda.gov.
In addition, your firm manufactures a variety of non-seafood sandwich products. The violation of Part 110 found during our inspection causes your sandwich products to be adulterated within the meaning of Section 402(a)(4) of the Act [21 USC 342(a)(4)] because 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 heath.
We acknowledge receipt of your firm’s response dated March 21, 2011, regarding the observations noted on the Form FDA 483, Inspectional Observations (FDA 483) issued to Mr. B. Keith Sullivan, General Manager, on March 3, 2011. Your responses are addressed below in relation to each violation, as applicable.
Your significant violations were as follows:
Seafood HACCP
1. You must conduct or have conducted a hazard analysis for each kind of fish and fishery product which you produce to determine whether there are food safety hazards which are reasonably likely to occur. You must have and implement a written HACCP plan, at a minimum, which lists the food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). 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.” However, your firm’s HACCP plan for Modified Atmosphere Packaged Sandwiches (including Tuna Salad sandwiches) does not list the food safety hazard of scombrotoxin (histamine) formation. Scombrotoxin (histamine) formation is a food safety hazard which is reasonably likely to occur in your Tuna Salad sandwiches.
For additional information and guidance related to the hazard of histamine (scombrotoxin) formation, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazards Guide), available through links in FDA's Internet home page at www.fda.gov or directly at http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/seafood/fishandfisheriesproductshazardsandcontrolsguide/default.htm.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Modified Atmosphere Packaged Sandwiches (including Tuna Salad sandwiches) at the metal detection critical control point to control metal inclusion is not appropriate.
Your HACCP plan lists “[r]emove contaminated product” as the corrective action for the detection of metal in your finished product. Metal-to-metal contact and equipment with metal parts which can break loose are likely sources of metal that may enter food during processing, yet your corrective action plan fails to address the possibility that metal fragments found in your product are the result of problems with the equipment in your facility. FDA recommends when a product rejected by a metal detector is evaluated and found to contain a metal fragment, you take the corrective action of attempting to locate and correct the source of the fragments found in the product by the metal detector.
For example, your Corrective Action Report for March 1, 2011, documents Line 1 was stopped during processing of Tuna Salad Lot Number 060. The report documents the “metal detector stopped” and, under the column entitled “Action taken: Product” states “isolated problem sandwich & took apart running through metal detector until I found problem.” Your quality control manager stated to our investigators the manufacturing equipment was not broken down or inspected and it was assumed by the firm that the metal fragment came from raw ingredients. This response failed to ensure the cause of the deviation was corrected, as the metal fragment may have originated from your facility’s equipment.
Your firm’s response states you will implement a new procedure for such occurrences “to stop production on the affected line until a reasonable assurance of the cause or in some cases the exclusion of causes has been made.” However, your firm’s response is not adequate as it does not refer to modifying your firm’s HACCP plan, nor does it include documentation of your firm’s new procedure.
For additional information and guidance related to the hazard of metal inclusion, please refer to Chapter 20 of the Hazards Guide.
Current Good Manufacturing Practice (CGMP) for Manufacturing, Packing, or Holding Human Food
1. Your plant and facilities must be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept in good repair; and, that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4). However, our investigators observed in your facility’s production area:
• Condensate dripping directly over three sandwich production lines where food products were exposed and over packaged sandwiches from production line two.
• Condensate located directly above the assembly line during the production of sandwiches before packaging on line three.
• Condensate draining directly onto the floor from a PVC pipe approximately two inches above the floor on the east wall adjacent to production line three.
• Peeling flooring material approximately four feet west of production line one and directly adjacent to the slicer on production line two in an area at least six feet long by twelve feet wide.
• A piece of the floor, approximately one inch by one-half inch, broke from the floor during production of closed-faced chicken salad sandwiches.
• Peeling paint on the production room east wall, adjacent to production line three and below hanging cleaning utensils.
• Paint chips on the production area floor while sandwiches were being assembled approximately three feet away.
• Condensate from the air conditioning unit was observed draining directly onto the floor of the production area along the west wall approximately five feet from production line two.
Your firm’s March 21 response states that by the end of April 2011, you will take corrective actions to your firm’s physical facility to correct the above listed violations. Your firm’s corrective actions will be evaluated during our next inspection.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, but not limited to, seizure and/or injunction.
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 regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We have the following additional comment:
• On February 28 and March 1, 2011, the strength of the iodine foot bath at the front entrance of the production room was tested and was found to have approximately 12 PPM iodine present. According to your firm’s Quality Control Manager, the foot baths should be maintained within 25-50 PPM iodine. During the inspection, our investigators collected environmental samples from your facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in subsample 22 of Sample 640388, collected from a footbath at the entrance to the production room.
To control L. monocytogenes, FDA recommends you consider the use of footbaths containing sanitizers when entering areas where refrigerated or frozen ready-to-eat foods are processed or exposed; however, FDA does not recommend you use footbaths in dry processing environments, where it may be more appropriate to use a dry powdered sanitizer. For non-automatic footbath sanitizers, FDA recommends that you check footbaths at regular intervals, such as hourly, to ensure they are filled with sanitizer and that the sanitizer is diluted to the proper concentration.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Ms. Asente at (504) 219-8818 extension 104.
Sincerely,
/s/
Monica Maxwell
Acting District Director
New Orleans District
cc: B. Keith Sullivan, General Manager
Great American Deli
P.O. Box 27
5828 Ooltewah-Ringgold Road
Ooltewah, Tennessee 37363-0027
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