FDA WARNING_LETTER - Olympus Medical Systems Corp. - November 10, 2022

On March 15, 2023, the FDA issued a Warning Letter to Olympus Medical Systems Corp. in Tokyo, Japan, following an inspection from November 7-10, 2022. The inspection revealed that the firm's endoscopes and accessories, including Single-Use Distal Covers and Suction Valve Accessories, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)(1))**: The firm did not initiate CAPA for approximately 160 "distal end cover dropped out" complaints, despite trending above expected numbers. Complaint investigations requiring reportability were not considered for CAPA. Non-conformances for package seal wrinkles were inappropriately handled as "yield control" instead of nonconforming product, risking sterility. The FDA deemed the firm's CAPA-200735 response inadequate, citing insufficient risk assessment for patient exposure to uncovered endoscopes and tissue injury. 2. **Failure to revalidate processes after changes (21 CFR 820.75(c))**: A modification to manufacturing equipment for package sealing (sterile product) was made without re-validation, despite observed wrinkles