FDA WARNING_LETTER - St Jude Medical CRMD - October 17, 2012

On January 10, 2013, the FDA issued a Warning Letter to St. Jude Medical Cardiac Rhythm Management Division (CRMD) following an inspection from September 25 to October 17, 2012, at their Sylmar, California facility. The inspection revealed that their Durata and Riata ST Optim high voltage implantable cardiac leads were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to validate processes** (21 CFR 820.75(a)): The firm used un-qualified holders for leads during a manufacturing process and did not challenge the process or test the adequacy of the produced items. 2. **Failure to monitor and control process parameters** (21 CFR 820.75(b)): The firm did not monitor the flow of a substance to machines as specified in their manual. 3. **Failure to establish and maintain adequate procedures for design verification** (21 CFR 820.30(f)): In-house test methods for Durata design verification were not validated, a test procedure was not followed (leads tested once instead of five times), and design verification was performed before design inputs were established. 4. **Failure to