FDA Inspection
Konsyl Pharmaceuticals IncKonsyl Pharmaceuticals Inc – FDA Inspection, Nov 21, 2014
Record Details
This FDA Inspection record concerns Konsyl Pharmaceuticals Inc, with an inspection on November 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Konsyl Pharmaceuticals Inc
- Inspection Date
- November 21, 2014
- Product Type
- Devices
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ID · b21c6800-372d-4301-b8ac-05f7c669fab3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906071
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Konsyl Pharmaceuticals Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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