FDA Inspection
Admedes GmbHAdmedes GmbH – FDA Inspection, Jun 25, 2009
Record Details
This FDA Inspection record concerns Admedes GmbH, with an inspection on June 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Admedes GmbH
- Inspection Date
- June 25, 2009
- Product Type
- Devices
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ID · 97031914-24ab-4f5e-9a2b-e0d6410521d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596171
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Admedes GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 2, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Admedes GmbH
- FDA Inspection 1210941 - 2023-06-15
- FDA Inspection 1078412 - 2018-12-07
- FDA Inspection 908900 - 2014-12-11
- FDA Inspection 711358 - 2011-03-02
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