FDA 483 - Unimicro Medical Systems (Shenzhen) Co., Ltd. - September 26, 2021

An FDA inspection conducted at Unimicro Medical Systems (Shenzhen) Co., Ltd. from September 15 to September 26, 2021, identified ten significant observations regarding the company's quality system for its Class II sterile Veress Pneumoperitoneum Needles, which are intended for the U.S. market. These findings highlight substantial deviations from regulatory requirements, primarily under the US FDA's Quality System Regulation (21 CFR Part 820).

Key deficiencies included inadequate design control procedures, with a notable absence of documentation for critical design activities such as input, output, review, verification, and validation. The firm also failed to maintain Device Master Records and adequately document process validation for essential manufacturing steps like sterilization, packaging, and UV glue curing. Corrective and preventive action (CAPA) procedures were found to be insufficient, lacking clear definitions for severity levels and criteria for conducting root cause analyses.

Further observations revealed a lack of documented calibration for manufacturing equipment and a failure to properly identify the acceptance status of products. The inspection also noted inadequate control over product location, with finished devices stored at an unregistered facility. Procedures for in-process product acceptance, control of nonconforming products, and Device History Records were also deficient. Critically, company personnel demonstrated a lack of familiarity with US FDA regulations governing medical device manufacturing and export. Unimicro Medical Systems has committed to addressing these observations and implementing the necessary corrective actions to ensure compliance.