| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesSeptember 14, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 52
Thomas P. Hand
Chief Executive Officer
Gilman Cheese Corporation
P.O. Box 187
Gilman, Wisconsin 54433
Dear Mr. Hand:
The Food and Drug Administration (FDA) conducted an inspection of your low-acid and acidified food manufacturing facility located at 300 South Riverside Drive Gilman, Wisconsin, on April 13, 18 and 21, 2011. The inspection found that your firm manufactures a variety of pasteurized process cheese, cheese foods and cheese products including a shelf stable pasteurized processed cheese food, and also smokes, packages, labels and codes natural cheeses made elsewhere. The inspection determined that you have significant deviations from the Low-Acid Canned Foods (LACF) regulations, Title 21, Code of Federal Regulations, Part 113 (21 CFR 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 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 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 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 on 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, no 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). Your firm manufactures pasteurized processed cheese with onion, pasteurized processed cheese food with onion, pasteurized processed cheese with jalapeno, pasteurized processed cheese food with jalapeno, and pasteurized processed cheese food which are not covered under your firm’s filed scheduled process with FDA.
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.
Scheduled processes must be 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.
2. Your firm failed to post in a conspicuous place near the processing equipment and to make readily available to the retort and processing system operator the processes and retort venting procedures as well as the scheduled process as required by 21 CFR 113.87. Specifically, the operators for the cooker and the lab technicians that conduct the (b)(4) critical control tests and their supervisors do not have access to the scheduled or filed process for the shelf stable products. In addition, the Quality Assurance Manager that reviews these records was not made aware there is a filed process to follow including critical factors and limits.
In your written response to the FDA-483 dated May 13, 2011, you indicate that after updating your scheduled process with your process authority, the process will be posted. However, your response did not address whether the shelf stable pasteurized cheese products are not being manufactured until the scheduled process is updated. The scheduled process must be available to your employees when the shelf stable pasteurized cheese products are being manufactured.
3. As a commercial processor of LACF products you must record and maintain records of the critical factors specified in the scheduled process, to comply with 21 CFR 113.100(a). However, you are not monitoring and recording the amount of (b)(4) in the shelf stable pasteurized processed cheese products, which is a critical factor specified by your process authority.
In your written response to the FDA-483 dated May 13, 2011, you indicate that you created a Recipe Checklist to be handed in on a daily basis to ensure the correct amount of ingredients are added, including (b)(4); however, you have not provided completed records that show the critical factor of (b)(4) levels are being properly monitored.
4. Your firm failed to mark each sealed container with a code that identifies the establishment where packaged, the product contained therein, the year packed, the day packed, and the period during which packed as required by 21 CFR 113.60(c). Specifically, you only identify product with a “Best By” code for your shelf stable Pasteurized Process Cheese Food product you have not established or implemented a code that includes the establishment where packed, product, year packed, day packed, and period during which packed.
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, Inspectional Observations, on May 13, 2011, and will verify your promised corrections during our next inspection.
Please respond in writing within 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 Food and Drug Administration, Attention: Demetria L. Lueneburg, Compliance Officer, at the address listed on this letterhead. If you have any questions with regard to this letter, you may contact Demetria Lueneburg at (612) 758-7210.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
dll/ccl
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