FDA WARNING_LETTER - Smith & Nephew, Inc. - November 26, 2013

On June 11, 2014, the FDA issued a Warning Letter to Smith & Nephew, Inc. following an inspection from November 12-26, 2013, at their Saint Petersburg, Florida facility, which manufactures Renasys Negative Pressure Wound Treatment (NPWT) devices. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate device design (21 CFR 820.30(g))**: Procedures did not ensure testing under actual/simulated use conditions, and risk-benefit assessments for identified hazards (e.g., exsanguination) were not performed. 2. **Failure to control design changes (21 CFR 820.30(i))**: Procedures for verifying/validating design changes and evaluating their impact on risk assessments were not established/maintained. For example, a change to the Renasys Go Pump's leak alarm sensitivity was not properly evaluated. 3. **Failure to implement corrective and preventive action (21 CFR 820.100(a))**: Complaint handling and post-market surveillance procedures lacked appropriate statistical methodology and effectiveness checks for corrective actions were not documented. 4. **Failure to investigate