Holymed Products Co., Ltd. – FDA EIR, Jun 19, 2019

A routine FDA inspection of Holymed Products Co., Ltd., a medical device contract manufacturer in Changzhou, China, was conducted from June 17-19, 2019. The inspection, focusing on Class I and Class II medical devices like surgical caps, shoe covers, and gowns, aimed to assess compliance with the FDA's Quality System Regulation. Two significant observations were noted on a Form FDA 483. First, the company failed to adequately establish and maintain procedures to control environmental conditions that could affect product quality (21 CFR 820.70(c)). This included not re-qualifying their "controlled environment area" since 2011, inconsistencies in environmental monitoring against established parameters, and a complete lack of environmental monitoring and cleaning records for Class I device production areas. Second, Holymed Products Co., Ltd. failed to maintain complete Device History Records (DHRs) for surgical caps manufactured prior to 2019, contrary to 21 CFR 820.184. Management acknowledged these issues, promising to implement corrective actions and provide a written response to the FDA within 15 business days. The inspection also noted a refusal by management to provide access to certain locked manufacturing and raw material storage areas, adding a layer of concern regarding transparency and control over all manufacturing operations.