FDA WARNING_LETTER - St. Jude Medical (CardioMEMS) - June 26, 2015

During an FDA inspection from June 8-26, 2015, St. Jude Medical (CardioMems) was found to be in violation of Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations (21 CFR Part 820) for their medical devices, including the CardioMEMS HF System. The inspection revealed that their devices are adulterated under Section 501(h) of the Act.

Key violations include: 1. **Inadequate Corrective and Preventive Action (CAPA) documentation (21 CFR 820.100(b))**: The firm failed to maintain an effective CAPA system and adequately investigate problems from customer complaints and non-conformances. Specific CAPAs (14-005, 14-004, 14-003) had overdue investigations, unclosed statuses, or incomplete approvals without justification for extensions. 2. **Undocumented and unapproved process validation (21 CFR 820.75(a))**: The annual re-validation of the CardioMEMS HF System sterilization process, due October 23, 2014, was not performed. 3. **Inadequate production process control (21 CFR 820.70(a))**: The (b)(4) process for medical devices was not adequately validated, lacking