| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human ServicesVIA United Parcel Service
April 15, 2011
Larry E. Brinkman, President
Brinkman Turkey Farms, Inc.
16314 U.S. Route 68
Findlay, OH 45840
WARNING LETTER CIN-DO 11-166633-09
Dear Mr. Brinkman:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food manufacturing facility located at 16314 US Route 68, Findlay, OH on January 24 – February 4, 2011. The inspection found that your firm cans the following low-acid canned foods in hermetically sealed cans: turkey and chicken broth; domesticated animals, such as beef, pork, chicken, and turkey not inspected by United States Department of Agriculture; wild game meats such as deer, elk, and bear; and wild-caught salmon. The inspection determined that you have significant deviations from the Low-Acid Canned Foods regulations, Title 21, Code of Federal Regulations, Part 113 (21 CFR Part 113).
As a manufacturer of low acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control and 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 United States Code (U.S.C.) § 344]. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113.
In addition, based upon certain criteria in 21 CFR 113, low acid foods may be adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the low-acid food regulations through links in FDA's Internet home page at http://www.fda.gov.
During the inspection, deviations were observed in your manufacturing operation. The observations of concern to us are as follows:
1. As a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers, you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimal initial temperatures, times and temperatures of processing, sterilization value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process for each low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). However, your firm has not filed any scheduled processes with FDA for each of the low-acid food products you manufacture.
Scheduled process information for low-acid foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm.
2. Your firm failed to have evidence in the form of heat distribution data on file which demonstrates that adequate venting of air is accomplished in your vertical still steam retorts as required by 21 CFR 113.40(a)(12)(iii). Specifically, the venting configuration of your vertical still steam retort, as described in the FDA-483, differs from the specifications and diagrams in the regulation and you have no data that shows that air is adequately vented in your configuration.
3. Your firm fails to record processing and production information at the time it is observed as required by 21 CFR 113.100(a)(1). Specifically, your firm does not record actual times for the following: 1. actual time that the retort reaches processing temperature; 2. actual venting time; and 3. actual processing time, as required by 21 CFR 113.100(a)(1). Your firm calculates processing time by adding 5 minutes to the time that the vent is closed; the time the vent is closed is calculated by adding 5 minutes to the time that the steam is turned on; and processing time is determined by adding the number of minutes that elapses from the recorded time that the processing temperature is reached.
In your written response to the FDA 483, you state that you will begin recording the actual time the retort reaches processing temperature; however, it isn’t clear if you intend to record the actual venting time and actual processing time. An estimation of these times is not adequate.
4. Your firm does not have scheduled processes that have been established by qualified persons having expert knowledge acquired through appropriate training and experience in the thermal processing of low-acid foods in hermetically sealed containers, as required by 21 CFR 113.83. Specifically, your firm does not have scheduled processes for your custom-processed wild game meats, such as elk, deer, and bear canned in 401 x 411 size cans.
5. Your firm’s recall procedure does not include procedures for determining the effectiveness of such recall as required by 21 CFR 108.35(f). We note that the “HACCP Recall for FDA Products” document, submitted in your written response, states that you will determine the effectiveness of a recall; however, the submitted recall plan does not specify your procedures for determining recall effectiveness.
This letter is not intended to be an all-inclusive list of deficiencies in your plant and your product label. It is your responsibility to ensure that all of your products comply with the Act, the low-acid canned food regulations (21 CFR 108 and 113), and the Current Good Manufacturing Practice regulation (21 CFR 110), and other applicable regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as seizure or injunction. Please note that we have received your written response to the FDA 483, dated March 9, 2011, and will verify your promised corrections during our next inspection.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Your response should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have any questions with regard to this letter, you may contact Karen Gale Sego at (513) 679-2700 extension 164 or via e-mail: karen.sego@fda.hhs.gov.
Sincerely,
/s/
Teresa C. Thompson
District Director
Cincinnati District
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