FDA WARNING_LETTER - Italfoods, Inc. - July 08, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Italfoods, Inc. from June 15 through July 8, 2020, following a previous inspection in July 2018. The inspection was initiated due to the isolation of Listeria monocytogenes from Pecorino Toscano DOP Stagionato Cheese imported by Italfoods. The FDA found significant violations of the FSVP regulation (21 CFR part 1 subpart L) for imported cheese products. Key deficiencies included failure to conduct or adequately document review and assessment of a hazard analysis (21 CFR 1.504), inadequate foreign supplier approval and verification processes (21 CFR 1.505), and lack of established and followed written procedures for importing only from approved suppliers and conducting verification activities (21 CFR 1.506). Italfoods also failed to promptly reevaluate supplier performance and risk after becoming aware of the Listeria positive result (21 CFR 1.505(c)(1)) and did not take appropriate corrective actions when verification activities were insufficient (21 CFR 1.508(a)). The firm's responses to the FDA 483a were deemed inadequate due to a lack of supporting documentation. Italfoods must take prompt corrective action and respond within fifteen working days with documentation of corrections. Failure to comply may result in refusal of admission for their imported cheese products and potential detention without physical examination (DWPE) under Import Alert #99-41.