Global Medical Production Co., Ltd. – FDA Warning Letter, Apr 30, 2015

On August 28, 2015, the FDA issued a Warning Letter to Global Medical Production Co., Ltd. following an inspection from April 27-30, 2015, which found their laparoscopic instruments to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to validate processes (21 CFR 820.75(a)):** The firm did not document (b)(4) for (b)(4) used in Tyvek packaging, lacked acceptance criteria for (b)(4), and failed to validate the (b)(4) for stainless steel instruments and the ultrasonic cleaning process. The firm's response was inadequate as it didn't confirm evaluation of other processes or address ultrasonic cleaning. 2. **Inadequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)):** The CAPA procedure lacked requirements for quality data analysis, statistical methodology, verification/validation of CAPAs, and dissemination of quality problem information. The firm's response was inadequate, as it didn't include implementation plans or a retrospective review of past CAPAs. 3. **Failure to establish purchasing requirements (21 CFR 820.50(b)):** The purchasing