FDA 483 - Global Medical Production Co Ltd - July 30, 2021

An FDA inspection conducted from July 15 to July 30, 2021, at Global Medical Production Co., Ltd. in Jiaxing, China, identified ten significant violations of U.S. FDA regulatory requirements for medical device manufacturers. The findings primarily concern deficiencies within the company's quality system, governed by 21 CFR Part 820, and Medical Device Reporting (21 CFR Part 803) for devices destined for the U.S. market. Major issues included the absence of established procedures for managing customer complaints and medical device reports, a lack of comprehensive Design Control procedures, and a failure to maintain Device Master Records and Device History Records for Class II devices. Further observations noted inadequate process validation for heat sealing, improper identification of product acceptance status (including unsterilized products labeled as sterile), and insufficient control over nonconforming products. The company also lacked essential equipment maintenance schedules and demonstrated a general unfamiliarity with critical USFDA regulations among personnel. Global Medical Production Co., Ltd. responded to each observation with a "Promise to correct," indicating that comprehensive corrective actions are required to address these systemic quality system deficiencies.