Unimicro Medical Systems-Shenzhen Co., Ltd. – FDA Warning Letter, Sep 26, 2021

On January 6, 2022, the FDA issued a Warning Letter to Roly Lee following an inspection from September 15-26, 2021, in Shenzhen, China. The firm manufactures Veress Pneumoperitoneum Needles, classified as adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Nonconforming Product Control (21 CFR 820.90(a)):** Failure to establish and maintain procedures for nonconforming product disposition. The firm lacked a disposition process for heat-sealed nonconforming products, and staff were unaware of procedures. The corrective action plan was inadequate, lacking active risk evaluation and documentation of disposition. 2. **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain design control procedures. The firm could not provide documentation for design and development activities for Veress Pneumoperitoneum Needles. The corrective action plan was inadequate, lacking retrospective design control activities and assessment of nonconforming product distribution risks. 3. **Process Validation (21 CFR 820.75(b)):** Failure to adequately establish and maintain procedures for monitoring and control of validated processes. No objective evidence or data for