Inspections, Compliance, Enforcement, and Criminal Investigations
Bessinger Pickle Company, Inc. 27-Nov-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
November 27, 2006
Craig R. Carruthers
Bessinger Pickle Company Inc.
537 N. Court
Au Gres, MI 48703
Dear Mr. Carruthers:
On August 2-3, 2006, the Food and Drug Administration (FDA) inspected your acidified food manufacturing facility located at 537 N. Court, Au Gres, MI. During the inspection, we determined that your Baby Dill Pickles and Little Dill Pickles fail to comply with the Acidified Food regulations per Title 21, Code of Federal Regulations (CFR), Parts 108 and 114; and with applicable parts of the Current Good Manufacturing Practice provisions in 21 CFR Part 110. Failure to comply with all the requirements of 21 CFR 108.25 and mandatory portions of 21 CFR Part 114 constitutes a prima facie basis for the immediate application of the emergency permit control provisions of Section 404 of the Federal Food, Drug and Cosmetic Act (the Act) ( 21 U.S.C. 344). In addition, failure to adhere to the criteria in the mandatory portions of 21 CFR Part 114 and the criteria in 21 CFR Part 110 renders your acidified food adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)], in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through links in FDA's home page at HYPERLINK "http://www.fda.gov www.fda.gov .
The requirements of 21 CFR Parts 108 and 114 with which you are not presently in compliance include the following:
1. Your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing and packaging of acidified foods, to register and file a Form FDA 2541 with the FDA, as required by 21 CFR 108.25(c)(1). Our inspection revealed that your firm has been processing acidified foods for a minimum of 20 years and no registration has been filed with the FDA.
2. Your firm failed to provide the FDA with the process filing information on the scheduled processes for your Baby Dill Pickles and Little Dill Pickles, as required by 21 CFR Part 108.25(c)(2). Specifically, you have not filed, as necessary, information including 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 of these acidified foods in each container size.
3. Your firm failed to test and record the finished equilibrium pH of your products with sufficient frequency to ensure that values are not higher than 4.6, as required by 114.80(a)(2). During the inspection, our investigator determined that final equilibrium pH is not measured at your facility.
4. Your firm failed to maintain files on a current procedure for use for products under your control, including plans for recalling products that may be injurious to health, as required by 21 CFR 108.25(e).
5. Your facility is not constructed in such a way as to facilitate sanitary operations, nor is it kept in repair sufficient to prevent food from becoming adulterated, as required under 21 CFR 110.20(b)(4) and 110.35. Specifically, our investigator observed opened jars directly below droplets of condensate and flaking paint with rust-like residue on the ceiling (i.e., above the exposed jars).
The above-identified deviations are riot intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that all food products comply with applicable laws enforced by the FDA. We advise you to take prompt measures to correct any deviations, including those identified in this letter. Failure to promptly correct these deviations may result in regulatory actions without further notice, such as seizure, injunction and/or issuance of an. Order of Need to Obtain and Hold a Temporary Emergency Permit.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step to prevent the recurrence of similar violations. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your written reply should be directed to Paige E. Wilson, Compliance Officer at the above address. If you have questions concerning the contents of this letter, you may contact Ms. Wilson at (313) 393-8250.
David M. Kaszub
Acting District Director
Detroit District Office