Company
GermanyAdmedes GmbH, Pforzheim, Germany – FDA Inspections
Inspection records and compliance data for Admedes GmbH in Pforzheim. 5 FDA inspections on record, last inspected June 15, 2023.
Company Profile
This profile covers Admedes GmbH based in Pforzheim, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 25, 2009. Last inspected June 15, 2023.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 15, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1210941 |
| December 7, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1078412 |
| December 11, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 908900 |
| March 2, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 711358 |
| June 25, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 596171 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Admedes GmbH
FEI Number
3003956144
Address
Rastatter Str. 15, Pforzheim, Germany
Country
Germany
ID: 206edbf3-4260-4956-b93d-525c02857114