Company
United StatesAudifon-USA, Inc., Debary, FL – FDA Inspections
Inspection records and compliance data for Audifon-USA, Inc. in Debary, Florida. 4 FDA inspections on record, 1 Form 483, last inspected November 27, 2018.
Company Profile
This profile covers Audifon-USA, Inc. based in Debary, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 1, 2010. Last inspected November 27, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- Lack of or inadequate procedures3 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 27, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1072952 |
| July 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 978529 |
| May 8, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831106 |
| April 1, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 654100 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Audifon-USA, Inc.
FEI Number
3005384855
Address
403 Chairman Ct Ste 1, Debary, Florida 32713, United States
Country
United States
ID: c7c3a3e6-4877-40b6-bae9-8a4ba26af98a