Company
United StatesOPTI Medical Systems, Inc, Roswell, GA – FDA Inspections
Inspection records and compliance data for OPTI Medical Systems, Inc in Roswell, Georgia. 3 FDA inspections on record, 1 Form 483, last inspected March 29, 2017.
Company Profile
This profile covers OPTI Medical Systems, Inc based in Roswell, Georgia, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 19, 2010. Last inspected March 29, 2017.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation of validated process performance1 inspection
- Justification for not reporting1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1008841 |
| June 28, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 842223 |
| November 19, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 703519 |
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
OPTI Medical Systems, Inc
FEI Number
3004102403
Address
235 Hembree Park Dr, Roswell, Georgia 30076, United States
Country
United States
ID: 8c4101b9-1666-4889-8287-4a2b4095c3a2