Company
United StatesAudigence, Melbourne, FL – FDA Inspections
Inspection records and compliance data for Audigence in Melbourne, Florida. 1 FDA inspection on record, last inspected March 30, 2011.
Company Profile
This profile covers Audigence based in Melbourne, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected March 30, 2011.
Most cited issue areas
- Design control - no procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 30, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 717167 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Audigence
FEI Number
3007753310
Address
1050 W Nasa Blvd Ste 154, Melbourne, Florida 32901, United States
Country
United States
ID: 62055a4c-cd36-46e5-821a-c3dcfd796fad