Shandong Zibo Shanchuan Medical Instrument Co. Ltd. – FDA Warning Letter, Oct 27, 2011

The FDA issued a Warning Letter to Shandong Zibo Shanchuan Medical Instrument Co. Ltd. following an inspection from October 24-27, 2011, which found the firm's sterile syringes to be adulterated and misbranded. The inspection revealed significant non-conformities with the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) regulation (21 CFR Part 803). Key QS violations included failure to adequately validate processes, specifically sterilization (21 CFR 820.75(a)); failure to establish and maintain procedures for corrective and preventive actions (21 CFR 820.100(a)); lack of procedures for design changes (21 CFR 820.30(i)); inadequate equipment calibration and maintenance procedures (21 CFR 820.72(a)); and insufficient quality audits (21 CFR 820.22). Additionally, the firm failed to adequately maintain Device History Records (21 CFR 820.184) and Device Master Records (21 CFR 820.181(a)). The firm's piston syringes were also deemed misbranded due to a failure to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17(a)). These systemic quality management failures render the firm's devices subject to refusal of admission into the U.S. (detention without physical examination). The FDA requires a written response within fifteen business days detailing corrective actions, preventive measures, and a timeline for completion. Failure to correct these violations will also impact premarket approvals and Certificates to Foreign Governments.