Company
United StatesDynaRad X-Ray, LLC, Boca Raton, FL – FDA Inspections
Inspection records and compliance data for DynaRad X-Ray, LLC in Boca Raton, Florida. 4 FDA inspections on record, last inspected September 24, 2012.
Company Profile
This profile covers DynaRad X-Ray, LLC based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 30, 2010. Last inspected September 24, 2012.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Failure to submit2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 24, 2012 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 806938 |
| October 8, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 720727 |
| October 8, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 685196 |
| September 30, 2010 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 683675 |
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
DynaRad X-Ray, LLC
FEI Number
1000517792
Address
544 Nw 77th St, Boca Raton, Florida 33487, United States
Country
United States
ID: afe12188-253e-462e-a5c8-3b17ad00d8ab