FDA WARNING_LETTER - Euro Diagnostica AB - January 19, 2017

On September 20, 2017, the FDA issued a Warning Letter to Euro Diagnostica AB following an inspection from January 16-19, 2017. The inspection revealed that the firm's Class II in vitro diagnostic devices, including the Euro-Diagnostica CCPoint, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain adequate procedures for timely complaint handling, evaluation for Medical Device Reportability, and complete documentation of investigations and replies. The firm's responses were deemed inadequate as they lacked evidence of established and approved procedures. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(b)):** Failure to document all CAPA activities and results, specifically for CAPA 2015-12. The firm's responses were inadequate, lacking evidence of formal documentation and retrospective review of past CAPA activities. 3. **Design Review (21 CFR 820.30(e)):** Failure to establish and maintain procedures ensuring formal documented design reviews at appropriate stages, including inclusion of all meeting minutes in