FDA Inspection
Dexcel Pharma Technologies - Yokneam FactoryDexcel Pharma Technologies - Yokneam Factory – FDA Inspection, Jul 17, 2019
Record Details
This FDA Inspection record concerns Dexcel Pharma Technologies - Yokneam Factory, with an inspection on July 17, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1048fa98-2689-49c7-b99b-bb53226b1f31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096505
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Dexcel Pharma Technologies - Yokneam Factory
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dexcel Pharma Technologies - Yokneam Factory
- FDA Inspection 964374 - 2016-02-25
- FDA Inspection 836503 - 2013-05-29
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