FDA WARNING_LETTER - Amico Laboratories, Inc. - September 20, 2007

On September 10-14, 18, and 20, 2007, an FDA inspection of Amico Laboratories, Inc. in Nashville, Tennessee, revealed significant violations of Current Good Manufacturing Practices (CGMP) and Quality System (QS) regulations for their In-Vitro Diagnostic Test Kits, which are medical devices. The devices are deemed adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 351(h)].

Key violations include: - **Design Validation (21 CFR 820.30(g)):** Failure to establish and maintain adequate procedures for design validation, including risk analysis and real-time stability testing for expiration dates. - **Process Validation (21 CFR 820.75(a)):** Lack of validation for production protocols (antigens, reagents, controls), absorbance test interpretations, one-year expiration dating, preservative effectiveness, and container/closure systems. - **Production Process Controls (21 CFR 820.70(a)):** Inability to establish antigen quality from live cultures, use of expired Leptospira culture, and inadequate monitoring of freezer temperatures for cultures and serums. - **Equipment Suitability (21 CFR 820.72(a)):** Use of expired pH buffer solutions. - **Environmental Controls (2