FDA Inspection
Ranir, LLCRanir, LLC – FDA Inspection, Feb 27, 2014
Record Details
This FDA Inspection record concerns Ranir, LLC, with an inspection on February 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ranir, LLC
- Inspection Date
- February 27, 2014
- Product Type
- Devices
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ID · 1bea4766-0aea-4a10-8a00-6fa6886e52c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866413
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Ranir, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 28, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ranir, LLC
- FDA Inspection 1021914 - 2017-08-16
- FDA Inspection 951697 - 2015-10-28
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