FDA Inspection
O. R. Surgical Company Inc.O. R. Surgical Company Inc. – FDA Inspection, Nov 1, 2016
Record Details
This FDA Inspection record concerns O. R. Surgical Company Inc., with an inspection on November 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · adfba95e-1c6a-48ac-b48c-81b92370fae7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993046
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of O. R. Surgical Company Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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