FDA WARNING_LETTER - FRANZESE S.P.A. - November 05, 2013

The FDA inspected Franzese S.P.A., a low-acid canned food (LACF) facility in Palma Campania, Italy, on November 4-5, 2013, and issued an FDA-483 for serious deviations from 21 CFR 108 (Emergency Permit Control) and 21 CFR 113 (Thermally Processed Low-Acid Foods). The firm's subsequent email correspondence did not adequately address the observations. Significant violations include failure to process LACF in conformity with the scheduled process, failure to identify process deviations when critical factors were out of control, failure to ensure product initial temperature met the scheduled process, and failure to equip retorts with accurate temperature-indicating devices. These violations render the firm's LACF products adulterated under Section 402(a)(4) of the Act. The FDA requires a written response within 15 working days, outlining specific corrective actions, supporting documentation, and revised scheduled processes. Failure to comply may result in refusal of admission for imported products under Section 801(a) of the Act, including Detention Without Physical Examination (DWPE) and placement on Import Alert #99-04. Additionally, the firm may be assessed reinspection fees.