Prince Medical Industry SUARL – FDA Warning Letter, Mar 28, 2012

On August 6, 2012, the FDA issued a Warning Letter to Prince Medical, a manufacturer of sterile and non-sterile diagnostic urodynamic catheters in Ercuis, France, following an inspection from March 26-28, 2012. The inspection revealed that the firm's 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 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a), (b), (e)):** Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints, including defining complaints, documenting receipt dates, evaluating for MDR reportability, investigating all necessary complaints, and maintaining complete investigation records. The firm's response was inadequate as it did not commit to investigating past complaints for MDR reportability or providing documentation of corrective actions and training. 2. **Design Changes (21 CFR 820.30(i)):** Failure to establish and maintain