Inspections, Compliance, Enforcement, and Criminal Investigations
Safie Specialty Foods Co., Inc 3-20-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, Ml 48207
RETURN RECEIPT REQUESTED
March 20, 2009
Ms. Mary D. Safe, President
Safie Specialty Foods, Co., Inc.
25565 Terra Industrial Drive
Chesterfield, MI 48051
The Food and Drug Administration (FDA) conducted an inspection of your acidified food manufacturing facility, located at 25565 Terra Industrial Drive, Chesterfield Township, MI on November 20-26, 2008. The inspection revealed that you manufacture several varieties of acidified food products at this 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 regulations were 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 filling of process information, and the mandatory requirements in 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 www.fda.gov.
During the inspection, our investigators documented deviations from the Act and the above-mentioned regulations relating to the processing of your Dill Pickled Beans, Crispy Dill Pickled Okra, Home Style Sweet Pickled Beets, Old Fashioned Bread and Butter Pickles, Mild Banana Peppers, Hot Banana Peppers, Hot & Zesty Garden Mix, and Pickled Asparagus acidified food products that cause these products to be adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)].
We have reviewed your firm's response to the FDA 483, dated January 15, 2009, and have included our comments as appropriate in the numbered paragraphs below.
The significant violations were as follows:
1. Your firm failed to provide, not later than 60 days after registration and before packing any new product, FDA information on 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). Specifically, you have manufactured the following acidified products and have not filed a scheduled process with FDA for these products: Dill Pickled Beans, Crispy Dill Pickled Okra, Home Style Sweet Pickled Beets, Old Fashioned Bread and Butter Pickles, Hot & Zesty Garden Mix, and Pickled Asparagus.
Scheduled process information for acidified foods must be submitted on Form FDA 2541 a (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.
Your response letter dated January 15, 2009, does not adequately address this violation. Although it indicates that you have submitted your scheduled process, as of the date of this letter, FDA has not received process filings for these products.
2. Your firm failed to 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). Specifically, your firm did not document the critical control measurement of pH on six separate production control sheets for acidified products manufactured between January 4 and April 29, 2008.
Your response letter dated January 15, 2009, does not adequately address this violation. Although it indicates that you intend to ensure that final product pH values do not exceed 4.6, it not describe whether or how you will ensure that the final equilibrium pH values are recorded.
3. Your firm failed to mark each acidified food container with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed, as required by 21 CFR 114.80(b). Your response letter dated January 15, 2009, does not adequately address this violation because it states that you intend to only add the packing period, but not the remaining information required by 21 CFR 114.80(b).
Your Padre Pio's Mild Pepperoncini Pepper product is also misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and fails to declare the common or usual name of each ingredient. Specifically, the certified color additive FD&C Yellow No. 5 is not declared by its common or usual name, as required by 21 CFR 101.4(a)(1). Under 21 CFR 101.4(b)(1), ingredients used to color a food must be declared according to the requirements for color additives in 21 CFR 101.22. Under 21 CFR 101.22(k)(1), it is not necessary to include the "FD&C" prefix or the term "No." in the declaration (i.e., the label may state "Yellow 5"). However, the label of your Padre Pio's Mild Pepperoncini Pepper product declares "FDC Yellow" in the list of ingredients, which does not comply with the regulatory requirements.
Moreover, a color additive is deemed unsafe under section 721(a) unless its use is in conformity with the color additive's listing regulation. Therefore, because its label does not declare FD&C Yellow No. 5 in accordance with the listing regulation for this color additive, your Padre Pio's Pepperoncini Pepper product contains a color additive that is unsafe under section 721(a). Accordingly, your Padre Pio's Mild Pepperoncini Pepper product is also adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because it contains a color additive that is unsafe within the meaning of section 721(a).
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 assure that all of your products are in compliance with applicable statutes and regulations enforced by the FDA. 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 the 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 Steven B. Barber, Director, Compliance Branch, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Mr. Steven B. Barber at (313) 393-8110.
Joann M. Givens