Company
United KingdomOptos, PLC, Dunfermline, United Kingdom – FDA Inspections
Inspection records and compliance data for Optos, PLC in Dunfermline. 1 FDA inspection on record, 1 Form 483, last inspected January 26, 2017.
Company Profile
This profile covers Optos, PLC based in Dunfermline, United Kingdom.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected January 26, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of System for Determining MDR Events1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 26, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1004971 |
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
Optos, PLC
FEI Number
3003060634
Address
Queensferry House, Carnegie Campus, Enterprise Way, Dunfermline, United Kingdom
Country
United Kingdom
ID: f7a1382e-b031-417b-a11a-05bb562eedeb