FDA WARNING_LETTER - Smith & Nephew, Inc. - March 26, 2015

The FDA issued a Warning Letter to Smith & Nephew, Inc. following an inspection from March 4-26, 2015, at their Andover, MA facility. The firm, a specification developer for arthroscopy and gynecology devices including TRUCLEAR ULTRA Reciprocating Morcellators, was found to have adulterated devices due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Significant violations include: 1. **Failure to verify/validate CAPA effectiveness (21 CFR 820.100(a)(4)):** Eight corrective action reports lacked sufficient verification of effectiveness. For example, CAR 12-0014 for TRUCLEAR ULTRA Morcellators, addressing undersized sluff chambers and loss of visualization, was closed without effectiveness verification, and complaints persisted. Reworked lots were released before a Health Hazard Assessment was finalized, contrary to internal procedures. Other CAPAs (MMP 13-0003, MMP 13-0004, A13-0006) remained open with unverified corrections. The firm placed a hold on TRUCLEAR Ultra Reciprocating Morcellators 4.0 shipments and is conducting a new Health Risk Assessment. Systemic CAPA improvements are planned, with effectiveness verification by January 2016. 2. **Failure to control non-con