Drug factory · FDA FEI 3006076314
Apotex Research Private Limited
Plot No.1 And 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, Mar 15, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 1 with no problems, 5 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dasatinib | Tests it | Apotex Corp. | 60505-3816, 60505-3817 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 15, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 2, 2019 | No problems found | Bioresearch Monitoring | — |
| Nov 17, 2017 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 1, 2014 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Jul 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 22, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2010 | 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.
Jul 1, 2014 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: analysis; manufacture.