Inspections, Compliance, Enforcement, and Criminal Investigations
Mission Mountain Food Enterprise Center 19-Aug-08
Department of Health and Human Services
Public Health Service
August 19, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-31
Billie Lee, Executive Director
Mission Mountain Food Enterprise Center
405 Main Street SW
Ronan, Montana 59864-2710
Dear Ms. Lee:
During the period of June 11 through 17, 2008, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 405 Main Street SW, Ronan, Montana. The inspection revealed that you manufacture an acidified food product, (b)(4) at your facility.
As a manufacturer of acidified 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 acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114. In addition, based on certain criteria in Part 114, acidified foods may be adulterated within the. meaning of Section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or 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 may have become contaminated with filth, or whereby they may have been rendered injurious to health. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located through FDA's homepage at http://www.fda.gov (http://www.cfsan.fda.gov/~comm/lacf-toc.html).
During the inspection, the FDA investigator documented deviations from the Act and the above-mentioned regulations relating to the processing of the acidified food (b)(4) (b)(4). These deviations cause this acidified food product to be adulterated under section 402(a)(4) of the Act in that it has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
The significant violations are as follows:
1. As a commercial processor engaged in the thermal processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, at the time of the inspection, you had failed to file a scheduled process for the acidified food (b)(4) (b)(4).
Scheduled process information for acidified 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.cfsan.fda.gov/~comm/lacf-s1.html
2. You must manufacture, process, and package your acidified food products so that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods; further, your manufacturing of these products must be in accordance with the scheduled process established by your process authority, as required by 21 CFR 114.80(a)(1). The scheduled process established by your process authority, (b)(4) (b)(4) for your (b)(4) specifies that pH values in this product must be 4.2 or lower. Accordingly, pH values for this product must not exceed this limit. However, you failed to process and package this acidified food product so that a finished equilibrium pH value of 4.2 or lower was achieved and maintained in the finished food. Specifically, nineteen control/batch sheets created and maintained by your firm between the dates of November 3, 2007, and May 22, 2008, for the production of the acidified food (b)(4) document pH values from 4.8 through 5.8.
FDA analysis of samples of (b)(4) (b)(4) collected during the inspection confirms that you are failing to achieve a finished equilibrium pH value of 4.2 or lower in the finished food. FDA sample number 454379, consisting of 12 half-gallon containers of the product produced on May 22, 2008, was analyzed and found to have an average pH value of 5.45. FDA sample number 454380, consisting of 12 half-gallon containers of the product produced on May 21, 2008, was analyzed and found to have an average pH value of 5.48.
3. You must maintain processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, and containing sufficient additional information such as product code, date; container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production, as required by 21 CFR 114.100(b). However, you failed to maintain processing and production records showing adherence to scheduled processes, including records of pH measurements and other, critical factors. Specifically, your firm did not document the critical control measurement of pH on thirteen separate production control sheets for the acidified product (b)(4) (b)(4) manufactured between the dates of November 3, 2007, and May 22, 2008. Eleven of the same production control sheets, which did not have a pH recorded, also did not have the critical factor of the final product cook temperature recorded, and two production control sheets listed pH values above 4.6 but did not record any final cook temperatures.
4. You must note all departures from scheduled processes having a possible bearing on public health or the safety of the food and identify the affected portion of the product involved. Further, you must record these departures and make them the subject of a separate file delineating them, the action taken to rectify them, and the disposition of the portion of the product involved, as required by 21 CFR 114.100(c). However, your firm failed to note all departures from scheduled processes having a possible bearing on public health or the safety of the food and did not maintain a separate file or log that identifies departures from the scheduled process, the action taken to correct them, and the disposition of the product involved. Production control records between November 3, 2007 and May 22, 2008, for the acidified food (b)(4) show departures from the scheduled process in nineteen separate production batches; however, none of these departures became the subject of a separate file delineating them.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure; injunction and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and then time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Michael J. Donovan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Mr. Michael Donovan at (425) 483-4906.
Charles M. Breen