FDA Inspection
Karl Storz SE & Co. KGKarl Storz SE & Co. KG – FDA Inspection, Oct 18, 2012
Record Details
This FDA Inspection record concerns Karl Storz SE & Co. KG, with an inspection on October 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Karl Storz SE & Co. KG
- Inspection Date
- October 18, 2012
- Product Type
- Devices
View Company Profile
ID · e012eb6c-9ecb-4c95-85d0-16561b475b66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807643
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Karl Storz SE & Co. KG
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 12, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 16, 2017 | Not classified | Office of Inspections and Investigations | |
| February 4, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Karl Storz SE & Co. KG
- FDA Inspection 1194478 - 2022-10-13
- FDA Inspection 1121364 - 2020-03-12
- FDA Inspection 1018675 - 2017-03-16
- FDA Inspection 647961 - 2010-02-04
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