Global Medical Production Co Ltd – FDA Warning Letter, Jul 30, 2021

The FDA issued a Warning Letter to a Chinese manufacturer of Sterile and Non-Sterile Electrosurgical Scissors, Sterile Electrosurgical Graspers, and Sterile Veress Pneumoperitoneum Needles following a July 2021 inspection. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Failure to control device design (21 CFR 820.30(a)):** No design control procedures or documentation for private label devices for the US market. This is a repeat violation from 2015. The firm's response was inadequate as it lacked assessment of impact on distributed devices and evidence of implementation. 2. **Failure to control nonconforming product (21 CFR 820.90(a)):** Procedures lacked requirements for evaluation, disposition, investigation, and notification for nonconforming products. The firm's response was inadequate, lacking assessment of risk from potential release of noncon