FDA Inspection
Aurobindo Pharma LtdAurobindo Pharma Ltd – FDA Inspection, Aug 10, 2018
Record Details
This FDA Inspection record concerns Aurobindo Pharma Ltd, with an inspection on August 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d05b0a30-90c9-4d0a-838e-86b02662c9d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061698
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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Other FDA inspections of Aurobindo Pharma Ltd
11| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 18, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aurobindo Pharma Ltd
- FDA Inspection 1210950 - 2023-07-21
- FDA Inspection 1155879 - 2019-07-05
- FDA Inspection 1090627 - 2019-05-24
- FDA Inspection 1010385 - 2017-04-18
- FDA Inspection 960797 - 2016-01-29
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