FDA Inspection
Aesculap Implant Systems LLCAesculap Implant Systems LLC – FDA Inspection, Jun 8, 2021
Record Details
This FDA Inspection record concerns Aesculap Implant Systems LLC, with an inspection on June 8, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aesculap Implant Systems LLC
- Inspection Date
- June 8, 2021
- Product Type
- Devices
View Company Profile
ID · a9561303-ed9e-4bc3-9b0c-8da6c5f92868
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1143458
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.72(b)Remedial action - documentation
Full citation text and observation details available on the Dashboard.
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 |
| March 4, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 916478 - 2015-03-04
- FDA Inspection 796358 - 2012-08-27
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.