Inaudi Commerciale Srl – FDA Warning Letter, Apr 28, 2010

On April 26-28, 2010, the FDA inspected Inaudi Commerciale Srl. in Borgo San Dalmazzo, Italy, and found serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113). These failures render their canned truffles adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, as the product was prepared, packed, or held under insanitary conditions.

Significant violations included: * Lack of documentation for the scheduled process for canned sliced truffles, not established by qualified persons (21 CFR 113.83). * No heat distribution data to prove adequate air venting in retorts (21 CFR 113.40(a)(12)(iii)). * A Colussi retort lacked a mercury-in-glass thermometer or equivalent (21 CFR 113.40(a)(1)). * Failure to record processing and production information, including actual processing times and thermometer readings (21 CFR 113.100(a)(1)). * Failure to conduct and record routine can double seam teardown exams (21 CFR 113.60(a)(1)).

The firm's May 1, 2010, response was deemed inadequate as it proposed corrections