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  5. Valley Foods Inc - 11/05/2014
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Valley Foods Inc

Valley Foods Inc

United States

Issuing Office:
Cincinnati District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237


VIA United Parcel Service
November 5, 2014
John A. Valley, Chief Executive Officer
Valley Foods, Inc.
335 E. Boardman St.
Youngstown, OH 44503
Dear Mr. Valley:
We inspected your food manufacturing firm, located at 335 E. Boardman St., Youngstown, OH, on July 29 – August 14, 2014. We found that you are in violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies 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) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your tuna salad is adulterated, in that it has 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 regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
Your response, dated August 25, 2014, has been received. However, your response is not adequate because the deviations noted during the inspection had not been corrected. 
The significant violation is as follows:
1)    You must conduct a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for tuna salad to control the food safety hazards of scombrotoxin (histamine) formation and allergens.
Your response, dated August 25, 2014, argues that your firm’s tuna salad processing prior to retorting is not a hazard because it does not exceed the critical limit time/temperature parameters listed on page 9 of the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition (Guide). Therefore, tuna salad processing prior to retorting is not a critical control point that would require inclusion into a HACCP plan.
The fact that your firm’s process is within the critical limits referenced in the Guide is irrelevant to whether or not a critical control point exists. Critical control points exist wherever control can be applied to prevent, eliminate, or reduce a food safety hazard. When critical control points exist, they must be controlled with a written HACCP plan.
We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. While the guidance is not a binding set of requirements it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy. 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulations (21 CFR Part 123), the Current Good Manufacturing Practice regulations (21 CFR Part 110), and the Food Labeling regulations (21 CFR Part 101). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act.  Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection.  A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved.  Reinspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act. 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. Your response should outline the specific steps you have taken to correct these violations. Your response should include your revised HACCP plans and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164 or karen.sego@fda.hhs.gov.
Paul J. Teitell
District Director
Cincinnati District
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