Boukhari Prince Medical BPM sa – FDA Warning Letter, Apr 2, 2012

On March 29-31 and April 2, 2012, an FDA inspection of Boukhari Prince Medical BPM sa in Bizerte, Tunisia, revealed that their Urodynamic Catheters and Regulator Administration Sets are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's April 23, 2012, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate processes, specifically for (b)(4), lacking a documented validation plan and general validation procedure. The firm's proposed plan lacked implementation evidence or global corrective actions. 2. **Purchasing Controls (21 CFR 820.50(a)):** Failure to establish and maintain adequate supplier requirements; (b)(4) of reviewed suppliers were not evaluated or on the approved list. Proposed procedure updates lacked implementation evidence. 3. **Complaint Handling (21 CFR 820.198(a)):** Inadequate procedures for receiving, reviewing, and evaluating complaints. The procedure did not define a complaint, commingled device complaints with non-conformances, and failed to require MDR