Amico Beds Corporation – FDA Warning Letter, Mar 12, 2015

On September 1, 2015, the FDA issued a Warning Letter to Amico Beds Corporation following an inspection from March 9-12, 2015, which found their A/C powered adjustable hospital beds to be adulterated and misbranded. The inspection revealed non-conformity with Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key violations include: 1. **Design Validation (21 CFR 820.30(g))**: Failure to establish and maintain procedures for validating device design, specifically for the Apollo Medsurg Powered Bed, under defined operating conditions using initial production units. The firm's retrospective validation was deemed inadequate. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a))**: Failure to adequately implement CAPA procedures. Five out of five CAPA reports lacked documentation of corrective action implementation or verification of effectiveness. The firm's response was inadequate as actions were incomplete and lacked systematic consideration. 3. **Device History Records (DHRs) (21 CFR 820.184)**: Failure to maintain adequate DHRs. DHRs for the Apollo Medsurg Bed lacked documentation of release stickers, signatures, and primary identification labels. The firm'