FDA Inspection
OptumHealth Care Solutions Inc.OptumHealth Care Solutions Inc. – FDA Inspection, Mar 8, 2018
Record Details
This FDA Inspection record concerns OptumHealth Care Solutions Inc., with an inspection on March 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 481f6fad-38e1-4e57-8181-018b33a2c5d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043518
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - review and approval
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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