FDA WARNING_LETTER - Karl Storz Endovision, Inc. - October 29, 2014

The FDA inspected Karl Storz Endovision, Inc. (Charlton, MA) from October 14-29, 2014, identifying significant Quality System regulation violations for their endoscopes, including the Flex-X 2 Flexible Ureteroscope. The devices were deemed adulterated under 21 U.S.C. § 351(h).

Key violations include: 1. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g))**: No design validation data for the Flex-X 2 cleaning brush. The firm's proposed design review and additional cleaning validations appear adequate, but a summary of the review and updated cleaning validation dates are required. 2. **Failure to establish and maintain procedures for verifying or validating corrective and preventive actions (CAPA) (21 CFR 820.100(a)(4))**: CAPA #1010 (cleaning brush fit) was closed without ensuring proper brush referencing for all affected models. CAPA #1012 (shaft composite assembly) was closed despite failed peel force acceptance criteria in validation. The firm's response was inadequate; a description of updated CAPA verification activities and evidence for previously closed CAPAs are required. 3. **Failure to develop, conduct, control, and monitor production processes (21 CFR 820.70(a))