FDA WARNING_LETTER - Neoventa Medical AB - April 01, 2010

On August 4, 2010, the FDA issued a Warning Letter to Neoventa Medical AB following an inspection from March 29 to April 1, 2010, which revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) regulation (21 CFR Part 803) for their fetal heart monitors. The devices were deemed adulterated and misbranded.

Key violations included: 1. **Corrective and Preventive Action (CAPA) Procedures (21 CFR 820.100(a)(4) and (b)):** Failure to establish and maintain adequate CAPA procedures, specifically lacking requirements for verifying/validating effectiveness and documenting these activities. The firm's response was inadequate as it only reviewed 10 CAPAs and lacked systemic corrective action. 2. **Complaint Handling Procedures (21 CFR 820.198(a)):** * Failure to ensure all communications alleging device deficiencies are handled as complaints. * Failure to uniformly process complaints, with documents not identified by complaint numbers and missing documents in complaint files. * Failure to include documentation of initial oral conversations in complaint files. The firm's responses were inadequate, lacking systemic corrective actions and retrospective reviews. 3. **Complaint Date in Investigation Records (21 CFR 8