Drug factory · FDA FEI 3005652193
Onesource Specialty Pharma Limited
Beta Lactam Division, 152/6 & 154/16, Doresanipalya, Bilekahalli, Bannerghatta Road, , Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 14, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2011: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ampicillin | Makes it, tests it, packages it, labels it and sterilizes it | Armas Pharmaceuticals Inc., Civica, Inc., Onesource Specialty Pharma Limited | 72485-421, 72485-422, 72485-423 +7 |
| Ampicillin and Sulbactam | Makes it, tests it, packages it, labels it and sterilizes it | Armas Pharmaceuticals Inc., Civica, Inc., Onesource Specialty Pharma Limited | 72485-416, 72485-417, 72485-418 +4 |
| Nafcillin | Makes it, tests it, packages it, labels it and sterilizes it | Armas Pharmaceuticals Inc., Onesource Specialty Pharma Limited | 72485-405, 72485-406, 83270-309 +2 |
| Oxacillin | Makes it, tests it, packages it, labels it and sterilizes it | Armas Pharmaceuticals Inc., Onesource Specialty Pharma Limited | 72485-409, 83270-306, 83270-307 |
| Piperacillin and Tazobactam | Makes it and tests it | Civica, Inc., Onesource Specialty Pharma Limited | 72572-414, 72572-418, 83270-301 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 14, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 1, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 3, 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.
Feb 14, 2019 inspection
- Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.