FDA Inspection
Aesculap Implant Systems LLCAesculap Implant Systems LLC – FDA Inspection, Mar 4, 2015
Record Details
This FDA Inspection record concerns Aesculap Implant Systems LLC, with an inspection on March 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aesculap Implant Systems LLC
- Inspection Date
- March 4, 2015
- Product Type
- Devices
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ID · e1ae88cf-a5bd-49da-932e-9f54d5bac3dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916478
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.72(a)Equipment control activity documentation
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Other FDA inspections of Aesculap Implant Systems LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aesculap Implant Systems LLC
- FDA Inspection 1223353 - 2023-11-09
- FDA Inspection 1143458 - 2021-06-08
- FDA Inspection 796358 - 2012-08-27
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