Company
United StatesSooka Inc, boca raton, FL – FDA Inspections
Inspection records and compliance data for Sooka Inc in boca raton, FL. 3 FDA inspections on record, last inspected February 14, 2018.
Company Profile
This profile covers Sooka Inc based in boca raton, FL, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 12, 2011. Last inspected February 14, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1050339 |
| October 30, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 904633 |
| October 12, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 750866 |
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
Sooka Inc
FEI Number
3007671445
Address
102 ne 2nd st ste 137, boca raton, FL 33432, United States
Country
United States
ID: 562592ad-3228-4287-a309-76a8d29b0f6c