FDA WARNING_LETTER - Aizu Olympus Co., Ltd. - July 08, 2022

On November 2, 2022, the FDA issued a Warning Letter to Yasuo Takeuchi of Aizu Olympus in Aizuwakamatsu, Fukushima, Japan, following an inspection from July 5-8, 2022. The firm manufactures sterile and non-sterile Endoscopes and Automated Endoscope Reprocessors, which are considered adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Violations include: 1. **Failure to validate device design (21 CFR 820.30(g))**: The firm did not validate the entire device design, such as image quality, for URF-V3/V3R and URF-P7/P7R, under actual or simulated use conditions. The firm's response to re-validate URF-P7 and revise procedures is ongoing, with corrective actions planned by November 18, 2022. 2. **Failure to validate processes (21 CFR 820.75(a))**: Bonding/gluing processes using (b)(4) and (b)(4) adhesives were not validated. The firm's response is inadequate, lacking clarity on sample size, previously distributed devices, addressing past curing times, and potential reprocessing issues. A