FDA Inspection
Karl Storz EndoscopyKarl Storz Endoscopy – FDA Inspection, Sep 12, 2024
Record Details
This FDA Inspection record concerns Karl Storz Endoscopy, with an inspection on September 12, 2024, issued by the Los Angeles District Office, covering medical devices & rad health.
- Company
- Karl Storz Endoscopy
- Inspection Date
- September 12, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 034364e1-1a5c-4139-8d18-320106cb1c46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249138
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Karl Storz Endoscopy
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 16, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 6, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Karl Storz Endoscopy
- FDA Inspection 1128796 - 2020-08-20
- FDA Inspection 1054311 - 2018-04-16
- FDA Inspection 868536 - 2014-05-06
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