Company
United KingdomOmega Laser Systems, Halstead, United Kingdom – FDA Inspections
Inspection records and compliance data for Omega Laser Systems in Halstead. 1 FDA inspection on record (1 OAI), last inspected September 10, 2015.
Company Profile
This profile covers Omega Laser Systems based in Halstead, United Kingdom.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected September 10, 2015.
Most cited issue areas
- Calibration procedures - content1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design control - no procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 944843 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Omega Laser Systems
FEI Number
3008440094
Address
Unit 2, Deans Hall Business Park; Oak Road, Halstead, United Kingdom
Country
United Kingdom
ID: d9609900-519b-489d-b7ce-667da1acbce3