FDA Inspection
Jell Pharmaceuticals Pvt. Ltd.Jell Pharmaceuticals Pvt. Ltd. – FDA Inspection, Dec 1, 2017
Record Details
This FDA Inspection record concerns Jell Pharmaceuticals Pvt. Ltd., with an inspection on December 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3683425c-486a-4c22-96c6-2fc231e1d573
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032397
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.80(d)Disposition recorded by lot identification
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
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Other FDA inspections of Jell Pharmaceuticals Pvt. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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