Company
United StatesSonablate Corp., Charlotte, NC – FDA Inspections
Inspection records and compliance data for Sonablate Corp. in Charlotte, North Carolina. 3 FDA inspections on record, 1 Form 483, last inspected August 02, 2022.
Company Profile
This profile covers Sonablate Corp. based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 26, 2014. Last inspected August 2, 2022.
Most cited issue areas
- Design validation - production units1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- DHR documentation of label release {see also 820.184}1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1176147 |
| November 29, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1032390 |
| March 26, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 874159 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sonablate Corp.
FEI Number
3007126306
Address
10130 Perimeter Pkwy Ste 410, Charlotte, North Carolina 28216, United States
Country
United States
ID: a8e942d3-47f4-4e7b-a995-ed7cc79635a7