Accuron Technologies (Dornier Medtech Systems GmbH ) – FDA Warning Letter, Apr 29, 2011

On August 26, 2011, the FDA issued a Warning Letter to Accuron Technologies (Dornier Medtech Systems GmbH) following an inspection from April 26-29, 2011, in Wessling, Germany. The inspection found that the firm's extracorporeal shock wave lithotripsy devices were misbranded under 21 U.S.C. 352(t)(2) due to failure to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Specifically, the firm failed to develop, maintain, and implement written MDR procedures (21 CFR 803.17). The existing procedure lacked provisions for timely event identification, standardized review for reportability, timely transmission of reports, and proper documentation and record-keeping for MDR-related information. The firm's May 18, 2011, response with a revised MDR procedure was deemed inadequate.

Additionally, the inspection identified several nonconformities with Current Good Manufacturing Practice requirements of the Quality System regulation (21 CFR Part 820): 1. Failure to establish and maintain adequate procedures for design validation and documentation (21 CFR 820.30(g)). 2. Failure to establish and maintain adequate procedures for design change control (21 CFR 820.30(i)). 3.