FDA Inspection
Karl Storz Endoscopy America IncKarl Storz Endoscopy America Inc – FDA Inspection, Jun 4, 2019
Record Details
This FDA Inspection record concerns Karl Storz Endoscopy America Inc, with an inspection on June 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a2701b40-20c7-4ddc-9720-aa0d694b33ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
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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 |
| May 24, 2022 | 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 1170790 - 2022-05-24
- FDA Inspection 998085 - 2017-01-10
- FDA Inspection 642593 - 2010-01-05
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