FDA WARNING_LETTER - Smith & Nephew Orthopaedics Gmbh - July 22, 2010

The FDA issued a Warning Letter to Smith & Nephew Orthopaedics Gmbh following a July 2010 inspection in Tuttlingen, Germany, which found their R3 Ceramic Acetabular Systems to be adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This was due to non-conformity with Current Good Manufacturing Practice requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's August 2010 response to the FDA 483 observations was deemed inadequate. Key violations included: failure to adequately validate processes (21 CFR 820.75(a)), specifically for pressing Titanium rings and bioburden/endotoxin testing; failure to establish and maintain adequate procedures to verify and validate corrective actions (21 CFR 820.100(a)(4)), as evidenced by recurring under-dosed sterilization batches; failure to control nonconforming product (21 CFR 820.90(a)) by not investigating sterilization failures; failure to document justification for using nonconforming product (820.90(b)), leading to the release of under-dosed batches; and failure to establish procedures for changes to specifications, methods, processes, or procedures (21 CFR 820.70(b)). The FDA found the firm's proposed corrective actions lacked sufficient evidence of implementation, proper protocols, or clear effectiveness. Smith & Nephew is required to take prompt action to correct these violations and respond in writing within fifteen working days, detailing specific steps, prevention plans, documentation, and a timetable. Failure to comply may lead to device detention, impact on federal contracts, denial of premarket approvals for Class III devices, and refusal of Certificates to Foreign Governments. A follow-up re-inspection will be conducted.