FDA WARNING_LETTER - Industrias Alimentarias De Navarra, S.A.U. - February 22, 2010

On May 27, 2010, the FDA issued a Warning Letter to Industrias Alimentarias de Navarra, S.A.U., following an inspection of their low-acid canned food facility in Casas del Monte, Caceres, Spain, from February 18-22, 2010. The inspection revealed serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113), rendering their canned black olives adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations included: 1. **Failure to record initial product temperature:** The firm did not determine and record the initial temperature of black olives prior to processing, as required by 21 CFR 113.87(c). This was observed during the inspection and in thermal processing records from December 23, 2009. 2. **Incomplete processing records:** Thermal processing records lacked critical factors such as actual processing times and Mercury-in-glass temperatures, violating 21 CFR 113.100(a)(7). 3. **Improper handling of process deviations:** The firm failed to properly identify and handle temperature process deviations during thermal processing in retorts, as required by 21 CFR 113.89. An investigator observed black olives being processed at a lower