FDA WARNING_LETTER - Caseificio Sociale Manciano Societa Agricola Cooperativa - February 17, 2012

The FDA inspected Caseificio Sociale Manciano, an Italian cheese processing facility, on February 16-17, 2012, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). This resulted in a Form FDA-483. The firm's Pecorino Toscano D.O.P., Pecorino Viminato and Crotonese, Bianchetta Truffle Cheese, and Pecorino Nocino with Walnuts cheeses were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions and misbranded under 21 U.S.C. § 343(h)(3). Key violations included a failure to design equipment to preclude food adulteration (21 CFR 110.40(a)), specifically concerning improperly located flow diversion valves on pasteurizers, which could contaminate milk with under-pasteurized product. The firm's proposed corrective action was deemed inadequate. Additionally, the cheeses were misbranded because their labels claimed pasteurized milk, but the milk was not pasteurized according to 21 CFR 1240.61 parameters, and no effectiveness data was submitted per Section 403(h)(3)(B)(i) of the Act. The FDA requires a written response within fifteen working days outlining specific corrections and supporting documentation. Failure to adequately respond may lead to refusal of admission for imported products, including Detention Without Physical Examination (DWPE), and assessment of re-inspection fees.