Aesculap AG – FDA Warning Letter, May 19, 2011

On September 26, 2011, the FDA issued a Warning Letter to Aesculap AG following an inspection from May 16-19, 2011, at their Tuttlingen, Germany facility, which manufactures devices including Craniofix and Yasargil Titanium Alloy Aneurysm Clips.

The inspection revealed that Yasargil Titanium Alloy Aneurysm Clips were misbranded under section 502(t)(2) of the Act due to the firm's failure to furnish required material or information under section 519 of the Act and 21 CFR Part 803 – Medical Device Reporting (MDR). Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR Part 803.17. The firm's procedure did not include requirements for MDR submission to FDA, nor did it establish internal systems for timely identification, communication, evaluation, and reporting of events, or for documentation and recordkeeping. The firm's June 1, 2011, response regarding this was deemed inadequate.

Additionally, the letter cited nonconformances with 21 U.S.C. § 351(h) and 21 CFR Part 820 (Quality System regulation). These included: 1. Failure to adequately confirm that design output meets design input requirements (21 CFR 820.3