FDA WARNING_LETTER - COVI S.A.S - December 07, 2012

The FDA inspected COVI S.A.S.'s low-acid canned food facility in St. Sebastien Sur Loire, France, on December 6 and 7, 2012, as a follow-up to a September 2011 inspection. The December 2011 letter regarding the previous inspection's deviations received no response.

The inspection revealed a serious, repeat violation: the firm failed to implement effective procedures to ensure the filed scheduled process is delivered as designed, specifically regarding critical factors. This violates 21 CFR 113.89. For example, on May 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 255°F. This constitutes a process deviation requiring corrective action or evaluation by a Process Authority. The firm's December 21, 2012, response acknowledged management and packaging changes but did not address this specific deviation.

COVI S.A.S. must comply with 21 CFR 108 and 21 CFR 113 for products exported to the U.S. Failure to comply can lead to emergency permit control provisions under Section 404 of the Act (21 U.S.C. 344), refusal of admission under Section 80