FDA Inspection
Konsyl Pharmaceuticals IncKonsyl Pharmaceuticals Inc – FDA Inspection, May 31, 2012
Record Details
This FDA Inspection record concerns Konsyl Pharmaceuticals Inc, with an inspection on May 31, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Konsyl Pharmaceuticals Inc
- Inspection Date
- May 31, 2012
- Product Type
- Drugs
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ID · 9ef21259-483f-41f8-af29-91bee87733d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784000
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Konsyl Pharmaceuticals Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 1, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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