FDA 483 - Taiji Medical Supplies Inc. - March 15, 2024

An FDA inspection of Taiji Medical Supplies Inc. in Lincolnton, NC, a manufacturer of surgical masks, revealed significant deficiencies in their quality system. The firm failed to adequately validate manufacturing processes, establish proper labeling controls, and ensure management review of quality system performance. Additional issues included inadequate purchasing controls, insufficient finished device acceptance procedures, and the use of obsolete documents.