FDA Inspection
Dexcel Pharma Ltd.Dexcel Pharma Ltd. – FDA Inspection, Jul 24, 2019
Record Details
This FDA Inspection record concerns Dexcel Pharma Ltd., with an inspection on July 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 22fbe152-1d95-4a72-a2b9-b19e079e4ac5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097285
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Dexcel Pharma Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 5, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dexcel Pharma Ltd.
- FDA Inspection 1195631 - 2022-12-14
- FDA Inspection 1007877 - 2017-02-16
- FDA Inspection 836838 - 2013-06-05
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