FDA Inspection
Ranfac CorporationRanfac Corporation – FDA Inspection, Jul 13, 2011
Record Details
This FDA Inspection record concerns Ranfac Corporation, with an inspection on July 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ranfac Corporation
- Inspection Date
- July 13, 2011
- Product Type
- Devices
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ID · 0c516181-0e75-4a1a-87ec-2bcca9267760
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 747227
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Ranfac Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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