FDA WARNING_LETTER - Applied Medical Technology Inc - April 29, 2011

On June 8, 2011, the FDA issued a Warning Letter to Applied Medical Technology, Inc. following an inspection from April 11-29, 2011, which found their sterile gastroenterology feeding tubes to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 C.F.R. Part 820).

Key violations include: 1. **Complaint Handling (21 C.F.R. § 820.198(c)):** Failure to establish adequate procedures for thorough complaint investigations, exemplified by an insufficient investigation into a "balloon burst" complaint. 2. **Corrective and Preventive Action (CAPA) (21 C.F.R. § 820.100(a)(1)):** Failure to adequately analyze quality records and work operations to identify causes of nonconforming product, specifically not capturing or analyzing machining scrap and not monitoring scrap rates. 3. **Nonconformity Investigation (21 C.F.R. § 820.100(a)(2) and (3)):** Failure to investigate the cause of high injection molding scrap rates (e.g., 46% for lot #100909