Aizu Olympus Co., Ltd.

Warning LetterOpen

Yasuo Takeuchi President and Chief Executive Officer Aizu Olympus Co., Ltd. 3-1 Nishi-Shinjuku 2-Chome Shinjuku-Ku Tokyo 163-0914 JapanFEI 3002964398Issued Nov 2, 2022Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002964398.

Violations4

Issue DateNov 2, 2022

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Aizu Olympus Co., Ltd.
Location: Yasuo Takeuchi President and Chief Executive Officer Aizu Olympus Co., Ltd. 3-1 Nishi-Shinjuku 2-Chome Shinjuku-Ku Tokyo 163-0914 Japan
FEI Number: 3002964398
Country: Japan
Issue Date: November 02, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Aizu Olympus Co., Ltd., a Japanese manufacturer of sterile and non-sterile endoscopes and automated endoscope reprocessors, was cited for failing to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The inspection conducted July 5-8, 2022 identified critical violations including failure to establish and maintain procedures for design validation to ensure devices conform to user needs and intended uses, with testing requirements not met for production units under actual or simulated use conditions. The company's July 29, 2022 response to FDA's Form 483 observations was found inadequate to address the systemic compliance deficiencies.

Aizu Olympus Co., Ltd. FDA Warning Letter, November 2, 2022