Company
United StatesDigisonics, Inc., Raleigh, NC – FDA Inspections
Inspection records and compliance data for Digisonics, Inc. in Raleigh, North Carolina. 3 FDA inspections on record, 1 Form 483, last inspected August 12, 2024.
Company Profile
This profile covers Digisonics, Inc. based in Raleigh, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 22, 2010. Last inspected August 12, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of System for Determining MDR Events1 inspection
- Lack of System for Event Evaluations1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 12, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1249267 |
| December 30, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009627 |
| November 22, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 695460 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Digisonics, Inc.
FEI Number
1626313
Address
305 Church At North Hills St Fl 6, Raleigh, North Carolina 27609, United States
Country
United States
ID: e9f827f8-8a68-4251-9145-aca9e0887668