FDA WARNING_LETTER - ARC Medical Supplies (Beijing) Co., Ltd. - December 14, 2010

The FDA issued a Warning Letter to ARC Medical Supplies (Beijing) Co., Ltd. following an inspection from December 6-14, 2010, which found that the firm's surgical sutures (devices) were adulterated under section 501(h) of the Act. This was due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820) for current good manufacturing practices. The inspection revealed five significant violations. Firstly, the firm failed to adequately validate processes, specifically ethylene oxide and gamma irradiation sterilization, as required by 21 CFR 820.75(a). Secondly, production processes were not properly controlled and monitored to ensure device specifications, with insufficient documentation from the contract sterilizer (21 CFR 820.70(a)). Thirdly, equipment maintenance schedules and documentation were inadequate for the microbiological hood and incubator (21 CFR 820.70(g)(1)). Fourthly, the firm lacked adequate procedures for document control, with unapproved standard operating procedures in use (21 CFR 820.40). Finally, there was a failure to identify the acceptance status of products, lacking documentation for raw material removal (21 CFR 820.86). The firm's December 27, 2010, response to the FDA 483 observations was deemed inadequate for all violations, citing insufficient information and a lack of systemic corrective actions. ARC Medical Supplies is required to notify the FDA within fifteen working days with specific corrective steps, including documentation and a plan to prevent recurrence. Failure to correct these issues will result in a follow-up inspection, potential denial of premarket approvals for Class III devices, and withholding of Certificates to Foreign Governments. Federal agencies will also be advised regarding contract awards.