FDA Inspection
OPTI Medical Systems, IncOPTI Medical Systems, Inc – FDA Inspection, Mar 29, 2017
Record Details
This FDA Inspection record concerns OPTI Medical Systems, Inc, with an inspection on March 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a859e0c5-57c1-4e06-85ba-4704d3489467
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008841
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of OPTI Medical Systems, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OPTI Medical Systems, Inc
- FDA Inspection 842223 - 2013-06-28
- FDA Inspection 703519 - 2010-11-19
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