FDA WARNING_LETTER - Cruz Perez Hermanos S.A. - February 19, 2010

On February 15-19, 2010, the FDA inspected Cruz Perez Hermanos S.A.'s low-acid canned food facility in Moana Pontevedra, Spain, and found serious deviations from 21 CFR Parts 108 and 113, rendering their Octopus in Oil product adulterated.

Key violations include: * **Failure to provide adequate process information (21 CFR 108.35(c)(3)(ii)):** The original scheduled process for Octopus in Oil (Oct. 13, 2009) could not be located, and supporting thermal studies did not match the actual process. The firm plans to conduct new studies, potentially requiring a revised filing. * **Improper use of reference thermometer (21 CFR 113.40(a)(1)):** The mercury-in-glass thermometer was not used as the reference for retort temperature readings. * **Failure to record initial temperature (21 CFR 113.87(c)):** Initial product temperatures were not recorded prior to processing. * **Inadequate record review (21 CFR 113.100(b)):** Production records were not signed as reviewed by qualified management within one working day. * **Failure to record visual closure examinations (21 CFR 113.60(a)):** Observations