FDA WARNING_LETTER - Quality Electrodynamics LLC - March 09, 2015

On February 10-March 9, 2015, an FDA inspection of Quality Electrodynamics, LLC, a manufacturer of MRI coils, revealed adulterated devices due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to adequately evaluate returned MRI coils for complaint definition. A retrospective review of repairs for the past two years revealed 10 burn reports and 28 heat reports not documented or investigated as complaints. The firm's response was inadequate as it did not address a retrospective review. 2. **Rework Documentation (21 CFR 820.90(b)(2)):** Failure to document rework and reevaluation activities on printed circuit boards in device history records. The firm's response, indicating revised procedures and ongoing training, requires an update on corrective action status. 3. **Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a)):** * Failure to implement the CAPA procedure, specifically not managing Engineering Change Orders for solder ball nonconformances as corrective actions, and not capturing surface mount technology (SMT) process nonconformances (e.g., missing components, solder balls