Inversiones Himalaya S.A – FDA Warning Letter, Jan 28, 2011

On January 27-28, 2011, the FDA inspected Inversiones Himalaya S.A. in Sechura, Peru, and found serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113). These failures render their low-acid canned food products, specifically canned seafood, adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, meaning they were prepared, packed, or held under insanitary conditions.

Significant violations include: 1. Failure to provide thermal distribution studies for (b)(4) as required by 21 CFR 113.40(a)(12)(iii), specifically lacking heat distribution data for retorts installed in September 2010 to ensure adequate air venting. 2. Not monitoring and recording processing and production information as required by 21 CFR 113.100(a), specifically failing to monitor and record the critical factor of particle size in Seafood Mix (b)(4). Additionally, processing records indicated inadequate control of critical factors like fill weight, drained weight, and drained to net weight ratios in various products.

While the firm's February 18, 2011, response satisfactorily addressed food GMP observations, it did not address the two aforementioned violations. The FDA requires a written response within thirty working days, outlining specific corrective