FDA WARNING_LETTER - Rechargeable Power Energy North America LLC - November 09, 2018

The FDA issued a Warning Letter to Rechargeable Power Energy North America, LLC following a November 5-9, 2018 inspection, identifying significant violations of the Quality System Regulation (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) for their Class III Automated External Defibrillator (AED) Batteries. The firm is a contract manufacturer of these batteries.

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a))**: Battery testing and calibration equipment were not validated, a repeat observation from a 2016 inspection. 2. **Inadequate complaint handling (21 CFR 820.198(a))**: No established procedures for receiving, reviewing, and evaluating complaints, including for MDR reporting, also a repeat observation. 3. **Lack of device history records (21 CFR 820.184)**: No procedures or records to demonstrate manufacturing in accordance with device master records, or documentation of components and finished product testing. 4. **Insufficient purchasing controls (21 CFR 820.50)**: No procedures for supplier evaluation and approval, or documentation of supplier evaluations, a repeat observation. 5. **Absence of acceptance activities procedures (21 CFR 820.80(b))**: No procedures for incoming product inspection or testing.