Drug factory · FDA FEI 3004446312
Aurobindo Pharma Limited
Unit-XII, Sy.No.314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, India
Serious problems, FDA action at FDA's last inspection, Sep 5, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
8 drug inspections on record since 2009: 1 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 5, 2025 | Serious problems, FDA action | Drug Quality Assurance | — |
| Mar 9, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 21, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 16, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 16, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 9, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 16, 2018 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Sep 17, 2010 inspection
- Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation.
Registered with FDA for: analysis; manufacture.