FDA Inspection
Konsyl Pharmaceuticals IncKonsyl Pharmaceuticals Inc – FDA Inspection, Aug 1, 2014
Record Details
This FDA Inspection record concerns Konsyl Pharmaceuticals Inc, with an inspection on August 1, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Konsyl Pharmaceuticals Inc
- Inspection Date
- August 1, 2014
- Product Type
- Drugs
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ID · 9dd661a7-726a-4e87-b493-cfa07caded5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888932
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/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 |
| May 31, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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