Hubertine Van Kessel
- Barnier Production
ZIA Du Barnier
- Issuing Office:
- Center for Food Safety and Applied Nutrition
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5001 Campus Drive
College Park, MD 20740
May 5, 2017
VIA EXPRESS DELIVERY
Hubertine Van Kessel, General Manager
ZIA Du Barnier
Frontignan, France 34110
Dear Ms. Van Kessel:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) and acidified food firm located at ZIA Du Barnier, Frontignan, France 34110, on January 16 - 17, 2017. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)), Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113), and the Acidified Foods regulation (21 CFR 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We have not received any correspondence from your firm in response to the FDA-483 indicating that you have corrected the observations of concern.
As a manufacturer of LACF and acidified food products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act, including those relating to the processing of low-acid foods packaged in hermetically sealed containers and acidified food products. 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 thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25 and 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113 and 114. Regulations specific to the processing of LACF and acidified food products are described in 21 CFR 108, 21 CFR 113, and 21 CFR 114.
As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, 21 CFR 108.35, 21 CFR 113, and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j) and 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25, 21 CFR 108.35,21 CFR 113, and 21 CFR 114 renders your LACF and acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act, LACF, and Acidified Food regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. Your firm failed to record a critical factor specified in the scheduled process, as required by 21 CFR 113.100(a). Specifically, on January 17, 2017, our investigator determined through record review that the finished product (b)(4) was not measured or recorded for all finished product lots processed under your firm’s scheduled processes for “Black Olives (Pitted or While) Dry Cured With or Without Herbs and Without Brine” packed in (b)(4) tin cans ((b)(4)) and flat pouches ((b)(4)) which state that a minimum of (b)(4) in the finished product is a critical factor of the process.
2. Your firm failed to manufacture your acidified food products in accordance with the scheduled processes, as required by 21 CFR 114.80(a)(1). Specifically, on January 16-17, 2017, our investigator determined the following deviations through review of your firm’s processing records:
a) There were several processing temperatures recorded (b)(4), though your scheduled process for "Green Olives w/ Herbes De Provence (Pitted)" ((b)(4)) in flat pouches (recipe number (b)(4)) states that the products are to be (b)(4).
b) There were several production dates where your firm did not document a minimum initial temperature (MIT) for processing in the pasteurization tunnel, though your scheduled process for "Green Olives w/ Herbes De Provence (Pitted)" ((b)(4)) in flat pouches (recipe number (b)(4)) identifies a MIT of (b)(4). In addition, on January 16, 2017, our investigator observed during production that you did not document initial temperatures during processing in the (b)(4).
c) There were several production dates where your firm did not document a minimum initial temperature (MIT) for processing in the (b)(4), though your scheduled process for “Marinated Garlic Gloves” ((b)(4)) in (b)(4) tin cans (recipe number (b)(4)) identifies a MIT of (b)(4).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF and acidified food products under section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the LACF and acidified food regulations (21 CFR 108, 113, and 114) is Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. This alert can be found on FDA’s web site at www.accessdata.fda.gov/cms ia/ialist.html.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including 21 CFR 108, 113, and 114 and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Clarice J. Ahn, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: firstname.lastname@example.org
. Please include reference #153908 on any submissions and within the subject line of any emails to us. You may also contact Clarice J. Ahn via email if you have any questions about this letter.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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