Company
United StatesBolton Medical Inc., Sunrise, FL – FDA Inspections
Inspection records and compliance data for Bolton Medical Inc. in Sunrise, Florida. 5 FDA inspections on record, last inspected November 20, 2019.
Company Profile
This profile covers Bolton Medical Inc. based in Sunrise, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected March 6, 2012. Last inspected November 20, 2019.
Most cited issue areas
- No IRB approval for treatment use1 inspection
- Sponsor securing investigator compliance1 inspection
- Sponsors" general responsibilities1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 20, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1111697 |
| September 16, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1103583 |
| September 12, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 987958 |
| August 23, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 844604 |
| March 6, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 775678 |
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
Bolton Medical Inc.
FEI Number
1000135961
Address
799 International Pkwy, Sunrise, Florida 33325, United States
Country
United States
ID: beea7e57-26fe-438a-a715-c879b7fdbd34