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

Source: https://www.keypedia.com/records/warning_letter/karl-storz-endovision-inc/eacae5de-3786-48e7-975d-7a076004b4bc

> FDA WARNING_LETTER for Karl Storz Endovision, Inc. on October 29, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Karl Storz Endovision, Inc.
- Inspection Date: 2014-10-29
- Product Type: Devices
- Office Name: New England District Office
- Summary: 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))

## Related Documents

- [EIR - 2021-09-17](https://www.keypedia.com/records/eir/karl-storz-endovision-inc/5eb239d0-52dd-4647-8747-277e4b9a0675)
- [483 - 2021-09-17](https://www.keypedia.com/records/483/karl-storz-endovision-inc/fc985e3d-2928-4ded-949a-59af235858f7)
- [483 - 2022-06-14](https://www.keypedia.com/records/483/karl-storz-endovision-inc/f7c2b3fb-1f4f-49c6-8575-a100157c415c)

## Related Officers

- [Gary Macker](https://www.keypedia.com/people/gary-macker/05132958-e0d9-46b2-9106-7ced13a82b76)
- [Compliance Officer](https://www.keypedia.com/people/karen-n-archdeacon/299d7f20-64be-4ada-a120-dab97b5938b5)
- [Karl – Christian Storz](https://www.keypedia.com/people/karl-christian-storz/4f020e1f-0313-4456-a6ac-57803cbb9fe1)
- [Serkan Sezer](https://www.keypedia.com/people/serkan-sezer/9092ffa4-60e7-4dc3-a4c8-a6146ea3ade7)
- [District Director](https://www.keypedia.com/people/mutahar-shamsi/f1ed0c75-3167-41cb-a918-130aa6d0fb07)

Company: https://www.keypedia.com/companies/karl-storz-endovision-inc/ccba1a5b-ab36-46d6-aa92-dbd2fab934b7

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144