FDA Inspection
Karl Storz Endoscopy America IncKarl Storz Endoscopy America Inc – FDA Inspection, May 24, 2022
Record Details
This FDA Inspection record concerns Karl Storz Endoscopy America Inc, with an inspection on May 24, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 24, 2022
- Product Type
- Devices
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ID · e154a7cc-6cbf-48b8-9b3a-6af25e387d50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1170790
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Karl Storz Endoscopy America Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 4, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 5, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Karl Storz Endoscopy America Inc
- FDA Inspection 1230647 - 2024-02-15
- FDA Inspection 1093439 - 2019-06-04
- FDA Inspection 998085 - 2017-01-10
- FDA Inspection 642593 - 2010-01-05
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