FDA Inspection
RNK Products, IncRNK Products, Inc – FDA Inspection, Feb 23, 2012
Record Details
This FDA Inspection record concerns RNK Products, Inc, with an inspection on February 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RNK Products, Inc
- Inspection Date
- February 23, 2012
- Product Type
- Devices
View Company Profile
ID · 22a9be4b-2def-4e38-8a91-41d2bc694181
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769356
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of RNK Products, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 19, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for RNK Products, Inc
- FDA Inspection 1038933 - 2017-12-14
- FDA Inspection 926848 - 2015-05-20
- FDA Inspection 583442 - 2009-05-19
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