Inspections, Compliance, Enforcement, and Criminal Investigations
Safie Specialty Foods Company Response Letter
May 1, 2009
U.S. Food and Drug Administration
Department of Health and Human Services
300 River Place, Suite 5900
Detroit, MI 48207
Mr. Steven B. Barber, Director, Compliance Branch
Re: FEI: 3003260771
Ms. Mary D. Safie, President
Safie Specialty Foods Company, Inc.
25565 Terra Industrial Drive
Chesterfield, MI 48051
Dear Mr. Barber:
Safie Specialty Foods Company, Inc . has received WARNING LETTER, 2009-DT-10 Dated March 20, 2009
Our Company has reviewed the Federal Food, Drug, and Cosmetic Act as described in Tile 21, Code of Federal Regulations Part 108, and Section 402 (a)(3) of the Act 21 U.S.C. 342(a)(4).
The following information pertains to the responses to FDA's observations and corrective actions taken by our company.
1. Your firm failed to provide, no 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 may 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 Food" available at http://wwwwcfsan.fda.gov/comm/lac-sl.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.
Safie Specialty Foods Company, Inc. has re-submitted schedule processes on April 14, 2009 for the following items. Please, find the attached fillings for all our products in Attachment A.
• Dill Pickled Beans
• Crispy Dill Pickled Okra
• Home Style Sweet Pickled Beets
• Old Fashioned Bread and Butter Pickles
• Hot & Zesty Garden Mix
• Pickled Asparagus
The proper format from our Process Authority (b)(4) and (b)(4) for the report which summarizes the re-analysis of existing data for determining safe heat processing times and temperatures for the production of acidified foods. The linear kinetics for Pickle Processing has enabled us to correct our current process filings and resubmit them with accuracy and comply with section, 21 CFR108.25(c) (2).
Safie Specialty Foods Company, Inc. has sent our company representative; (b)(6) Plant Manager, to attend, The Acidified Foods GMP School. It was Sponsored by:
• North Carolina Cooperative Extension Service Department of Food, Bioprocessing and Nutrition Sciences, North Carolina State University.
• Pickle Packer International, Inc.
In Cooperation With :
• Food Science Research Unit, US Department of Agriculture, ARS
North Carolina State University
• Food and Drug Administration US Department of Health and Human Services
• Seminar at North Carolina University,
Attachment "A" Filled Schedule Process
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 114.10(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 does not describe whether or how you will ensure that the final equilibrium pH values recorded.
Safie Specialty Foods Company, Inc., has developed the following procedure to adequate identify the information required by 21CFR 114.80(b). Our company has only ONE manufacturing facility. The facility is identified on the label which includes the address and phone number. The following information is printed on the lid and or container in the following order: Please Note, a photo sample of the Lid is attached.
1. Best Buy Date; specified as follows:
2. Morning Production or Afternoon Production; specified as follows:
AM or PM
4. Initials for Products Produced:
5. Lot Number is (b)(4)
Attachment "C" A Photo Sample of the Lid is Attached
4. Your Padre Pio's Mild Pepperoncini Pepper product is also misbranded within the meaning of Section 403(i)(2) of the Act (21 USB 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 of 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 no 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 in conformity with the color additive's listing regulation. Therefore, because of 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 a lot adulterated with the meaning of section 402(c) of the Act (21 USC 342(c) because it contains a color additive that is unsafe within the meaning of section 721(a).
There was an error in proof reading when the label was printed. At present, there are no Padre Pio's Mild Pepperoncini 32 oz. jars available to purchase in the market or for consumption. New labels are in the process of being printed with the corrected identification for FD&C Yellow #5 on the label. The correction will comply with the listing regulation for this color additive. The new label proof is available and an attachment is enclosed.
Attachment "D" Copy of the Label Proof
Mary D. Safie; President
Safie Specialty Foods Company, Inc .
25565 Terra Industrial Drive, Chesterfield, MI 48051
Remit to: P.O. Box 46333, Mt, Clemens, MI 48046
cc Joann M. Givens, District Director, Detroit District
Dr. Fletcher Arritt, III, Ph.D. Food Science Extension Leader, NCSU, Raleigh
Dr. M. Palnitkar, Ph.D. Consultant
John. Roberts, Plant Manager