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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.