Gyrus Medical – FDA Warning Letter, Aug 5, 2010

On August 2-5, 2010, an FDA inspection of Gyrus Medical Limited in Cardiff, UK, revealed that their endoscopic and electrosurgical devices were misbranded under 21 U.S.C. 352(t)(2) due to failures in Medical Device Reporting (MDR) procedures, as required by 21 CFR Part 803. The firm's MDR Procedure lacked the required reporting address, limited reportable adverse events, used inconsistent definitions for "serious injury" and "malfunction" compared to 21 CFR 803.3, omitted timeframes for supplemental reports (21 CFR 803.56), and combined various regulatory authorities' language, potentially causing confusion.

Additionally, the inspection identified nonconformities with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). These included: 1. Failure to maintain adequate equipment calibration procedures (21 CFR 820.72(a)), specifically for test timers. 2. Failure to establish and maintain adequate procedures for monitoring and control of process parameters for validated processes (21 CFR 820.75(b)), particularly regarding sterilization dose audits per ISO 11137. 3. Failure to maintain adequate Device History Records (DHRs) demonstrating manufacturing in accordance with the Device Master