Inspections, Compliance, Enforcement, and Criminal Investigations
COVI S.A.S 4/18/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
April 18, 2013
VIA EXPRESS DELIVERY
Mr. Patrice Bourigault
341, Route de Clisson
St. Sebastien Sur Loire 44233
Reference No. 393571
Dear Mr. Bourigault:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food facility located at 341, Route de Clisson, St. Sebastien Sur Loire 44233, France on December 6 and 7, 2012. During that inspection, we found that your firm had a serious deviation from the low-acid canned food regulation (Title 21, Code of Federal Regulations, Part 113, Thermally Processed Low-Acid Canned Foods in Hermetically Sealed Containers (21 CFR 113)). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, that listed the serious deviation found at the firm.
This inspection was a follow-up to the inspection at your firm on September 12 and 13, 2011. As a result of findings from the September 2011 inspection, we sent you a letter, dated December 22, 2011, to further explain the deviations noted during the inspection. Your firm did not respond to our December 2011 letter. FDA conducted another inspection of your facility on December 6 and 7, 2012. During the December 2012 inspection, we found that you have not implemented effective procedures to ensure that your filed scheduled process is delivered as designed. This is a repeat violation from the September 2011 inspection and was also brought to your firm’s attention in our December 2011 letter.
As a manufacturer of low-acid canned food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of low-acid canned food products for the low-acid canned foods that you export to the United States. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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 108.35(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. In addition, violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your low-acid canned 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 and the low-acid canned food regulations through links in FDA’s home page at http://www.fda.gov.
Your significant violation is as follows:
Your firm failed to identify, from a processor check or otherwise, deviations from the scheduled process of critical factors which are out of control, as required by 21 CFR 113.89. Specifically, your firm did not identify deviations from your filed scheduled process and critical factors that occurred during thermal processing of Couscous with Olive Oil (b)(4) destined for export to the U.S, during your review of processing records.
On 5/30/2012, two batches of Couscous with Olive Oil processed in retort F did not achieve the critical factor of 24 minutes come-up-time (CUT) at 255ºF. Any time the CUT is not met, you should consider the event a process deviation which requires that a corrective action be taken. If no corrective action is taken to compensate for the short CUT, your Process Authority needs to evaluate the deviation and write a report stating the condition of the product. Your process authority needs to reevaluate your process and determine the impact of the deviation on product safety and this evaluation record must be available for review.
The CUT needs to be satisfied because this is the amount of time required for the retort to achieve uniform temperature throughout. The first two minutes of the process start time or any amount of time considered to be process start cannot be associated with the CUT. Once the CUT is achieved, then the actual process time can begin.
We acknowledge receipt of your response on December 21, 2012. In your response, you informed us of some changes in management, intended changes to packaging of your product, and that the level of sterilization was at (b)(4) for Couscous with Olive Oil and that this was a correct value. Your response did not address any corrective action for the deviation described above.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violation identified and should include documentation that would assist us in evaluating your corrections. In addition, 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 low-acid canned 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 low-acid canned food regulations (21 CFR 108 and 113) is Import Alert #99-04. This alert can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the emergency permit control regulations and the low-acid canned food regulations (21 CFR 108 and 113). 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: Carol D’lima, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov. Please reference #393571 on any submissions and within the subject line of any emails to us. You may also contact Carol D’lima at (240) 402-2033 or email if you have any questions about this letter.
Office of Compliance
Center for Food Safety
and Applied Nutrition
Close Out Letter