Company
GermanyAudifon Gmbh, Kolleda, Germany – FDA Inspections
Inspection records and compliance data for Audifon Gmbh in Kolleda. 3 FDA inspections on record, 2 Form 483s, last inspected January 16, 2025.
Company Profile
This profile covers Audifon Gmbh based in Kolleda, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected May 11, 2017. Last inspected January 16, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Design validation- Lack of or inadequate procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1260616 |
| December 18, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1114379 |
| May 11, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1013135 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Audifon Gmbh
FEI Number
3006076696
Address
Werner-Von-Siemens-Str. 2, Kolleda, Germany
Country
Germany
ID: f0e62de7-b5b5-49b3-b8ec-b08e46b3f773