Drug factory · FDA FEI 3007512701
Mylan Laboratories Limited
(OTL), Plot No. 284-B, Bommasandra Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, India
Problems found, fixed voluntarily at FDA's last inspection, May 27, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dactinomycin | Makes it, tests it, packages it, labels it and sterilizes it | AuroMedics Pharma LLC | 55150-431, 55150-928 |
| Methotrexate | Makes it, tests it, packages it, labels it and sterilizes it | AuroMedics Pharma LLC | 55150-510, 55150-511, 55150-512 +1 |
| Mitomycin | Makes it | Archis Pharma LLC | 72819-152, 72819-153, 72819-154 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 27, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 4, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 13, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Sep 3, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 25, 2011 | 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.
May 27, 2022 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - In-process sample representation/identification 21 CFR 211.160(b)(2)
In-process samples are not representative.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.