FDA WARNING_LETTER - Huaiyin Medical Instruments Co., Ltd. - April 02, 2009

On March 30-April 2, 2009, an FDA inspection of Huaiyin Medical Instruments Co. LTD. in Huaian, China, revealed that their surgical devices are adulterated under section 501(h) of the Act, failing to conform with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's August 25, 2009, response was deemed inadequate.

Violations include: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** The firm lacked records for heat sealing process qualification for packaging and complete validation data for all sterilizers. The response claiming future validation and existing documentation was unsupported. 2. **Failure to establish adequate statistical techniques (21 CFR 820.250):** The firm's sampling criteria for absorbable suture material (b)(4) allowed retesting after initial failure, contradicting GB-2828-1-2003/ISO 2859-1 1999, which requires rejection without retesting. The firm's response did not address this. 3. **Failure to maintain an adequate complaint handling system (21 CFR 820.198(a)(3)):** The firm lacked a procedure to evaluate