FDA Inspection
Aurobindo Pharma LimitedAurobindo Pharma Limited – FDA Inspection, May 10, 2022
Record Details
This FDA Inspection record concerns Aurobindo Pharma Limited, with an inspection on May 10, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aurobindo Pharma Limited
- Inspection Date
- May 10, 2022
- Product Type
- Drugs
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ID · b9201ac7-5ec4-46dd-8aaf-7304c3c93094
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1169446
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Aurobindo Pharma Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2026 | Not classified | Office of Inspections and Investigations | |
| August 4, 2023 | Not classified | Office of Inspections and Investigations | |
| September 27, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aurobindo Pharma Limited
- FDA Inspection 1304312 - 2026-02-10
- FDA Inspection 1242351 - 2023-08-04
- FDA Inspection 1105823 - 2019-09-27
- FDA Inspection 1022788 - 2017-06-24
- FDA Inspection 927596 - 2015-03-13
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