Company
United StatesOptumHealth Care Solutions Inc., White Plains, NY – FDA Inspections
Inspection records and compliance data for OptumHealth Care Solutions Inc. in White Plains, New York. 1 FDA inspection on record, 1 Form 483, last inspected March 08, 2018.
Company Profile
This profile covers OptumHealth Care Solutions Inc. based in White Plains, New York, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected March 8, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - review and approval1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 8, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1043518 |
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
OptumHealth Care Solutions Inc.
FEI Number
3010521294
Address
1311 Mamaroneck Ave, White Plains, New York 10605, United States
Country
United States
ID: 5f8e40b5-4ed9-426a-9436-2236a37a9b86