FDA WARNING_LETTER - Primus Medical LLC - August 31, 2012

This FDA Warning Letter to Primus Medical LLC, dated October 17, 2012, details violations observed during an August 28-31, 2012 inspection of their Boardman, OH facility. Primus Medical LLC is the specification developer and initial importer of AC powered hospital beds, classified as medical devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 CFR Part 803 (Medical Device Reporting) and 21 CFR Part 806 (Reports of Corrections and Removals).

Key violations include: 1. **Purchasing Controls (21 CFR § 820.50):** Failure to establish and maintain procedures for purchased products and services, including inadequate vendor evaluation and lack of documented evaluations for contract manufacturers and most suppliers. 2. **Design Validation (21 CFR § 820.30(g)):** Failure to perform design validation for the PCB301/601 Low Bed devices distributed since June 2012. 3. **Corrective and Preventive Action (CAP