FDA Inspection
Apicore Pharmaceuticals Private LtdApicore Pharmaceuticals Private Ltd – FDA Inspection, May 5, 2023
Record Details
This FDA Inspection record concerns Apicore Pharmaceuticals Private Ltd, with an inspection on May 5, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e4437204-8031-4aa8-8e1c-be2de4ef72d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206636
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Apicore Pharmaceuticals Private Ltd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apicore Pharmaceuticals Private Ltd
- FDA Inspection 1113142 - 2019-11-08
- FDA Inspection 1040683 - 2018-01-25
- FDA Inspection 965189 - 2016-03-25
- FDA Inspection 885835 - 2014-06-13
- FDA Inspection 745467 - 2011-09-12
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