Karl Storz – FDA Warning Letter, Oct 29, 2009

On October 26-29, 2009, an FDA inspection of Karl Storz Endoskope in Garching-Hochbruck, Germany, revealed that their flexible video endoscopy devices are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820.

Violations include: 1. Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically the endoscope shaft cover process. 2. Failure to establish and maintain acceptance procedures for in-process product (21 CFR 820.80), as the test method for cover adherence to the endoscope shaft is not validated and lacks formal procedures. 3. Failure to verify or validate corrective and preventive actions (CAPA) for effectiveness and to ensure no adverse effects on finished devices (21 CFR 820.100(a)(4)), exemplified by a CAPA not identifying all affected product codes. 4. Failure to investigate the cause of nonconformities (21 CFR 820.100(a)(2)), with CAPA investigations documenting problems but not root causes. 5. Failure to document required CAPA activities and