Madama Oliva Srl – FDA Warning Letter, Jun 12, 2010

On August 5, 2010, the FDA issued a Warning Letter to Madama Oliva, S.R.L. following an inspection of their low-acid canned food (LACF) and acidified food facility in Carsoli, Italy, from June 10-12, 2010. The inspection revealed serious deviations from 21 CFR Parts 108 and 113, rendering their LACF products, specifically Black Cerignola Olives, adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: * Failure to notify FDA within 30 days of intentional changes to scheduled processes without scientific substantiation (21 CFR 108.35(c)(2)(ii)), specifically lowering the initial temperature of black cerignola olives. A revised filing was submitted but deemed insufficient. * Failure to determine and record initial temperatures of container contents to ensure they meet the minimum specified in the scheduled process (21 CFR 113.87(c)). * Failure to perform and record teardown examinations for double-seam cans to ensure seam integrity (21 CFR 113.60(a)(1)). * Failure to record observations of visual closure examinations (21 CFR 113.60(a)). * Failure to use the mercury-