FDA WARNING_LETTER - Farm Country Cheese House, Inc. - October 23, 2015

The FDA issued a Warning Letter to Farm Country Cheese House, Inc. following an inspection from October 13-23, 2015, which was a follow-up to a January 2015 inspection. The inspection documented serious and continued violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the firm's ready-to-eat cheeses adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations included failure to prevent contamination from production procedures (21 CFR 110.80), such as damaged equipment, improper tool storage, and inadequate cleaning/sanitization indicated by high APC counts. Plumbing issues, specifically lack of backflow prevention, were noted as a source of contamination (21 CFR 110.37(b)(3)). The firm also failed to operate air-blowing equipment to minimize contamination (21 CFR 110.20(b)(6)) and construct facilities to prevent drip/condensation from contaminating food (21 CFR 110.20(b)(4)). Personnel hygiene practices were deficient, with employees failing to wash hands properly (21 CFR 110.10(b)(3)). Lastly, food contact surfaces had rough or cracked welds, hindering proper cleaning (21 CFR 110.40(b)). The firm's written response to the FDA-483 was deemed inadequate for several violations, often lacking documentation of completed corrective actions, failing to address the root cause, or proposing insufficient solutions. Many observations were repeat violations, indicating a systemic failure in maintaining compliance. The FDA requires a written response within 15 working days outlining specific, documented corrective actions, with potential regulatory actions like seizure or injunction, and re-inspection fees for non-compliance.