FDA Inspection
AAP Implantate AgAAP Implantate Ag – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns AAP Implantate Ag, with an inspection on November 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AAP Implantate Ag
- Inspection Date
- November 19, 2009
- Product Type
- Devices
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ID · 3f7f8dc8-8a91-41b8-97d8-17fab20d1a59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 631136
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of AAP Implantate Ag
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 7, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 17, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AAP Implantate Ag
- FDA Inspection 1286384 - 2025-09-11
- FDA Inspection 1192265 - 2022-11-04
- FDA Inspection 1111642 - 2019-11-07
- FDA Inspection 1017003 - 2017-05-17
- FDA Inspection 917531 - 2015-02-12
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