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

Source: https://www.keypedia.com/records/warning_letter/olympus-medical-systems-corp/bf761185-bf42-44ee-9741-ab19d9dc9ea6

> FDA WARNING_LETTER for Olympus Medical Systems Corp. on November 10, 2022. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Olympus Medical Systems Corp.
- Inspection Date: 2022-11-10
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Acting Director](https://www.keypedia.com/people/courtney-h-lias/5e0a64fa-0140-4de2-9eed-929b12def9e9)
- [Todd Brill](https://www.keypedia.com/people/todd-brill/7ae23086-a2f4-459e-bd76-8ab057fe955f)

Company: https://www.keypedia.com/companies/olympus-medical-systems-corp/73731ceb-b5d9-41ff-aa38-29bb2f20de71

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7