Drug factory · FDA FEI 3003981475
Biocon Biologics Limited
Block No, B1, B2, B3, B5, Q13 of Q1 and W20 & Unit S18, 1st Floor, Block B4, SEZ, Plot No.2, 3, 4&5, Phase IV, Bommasandra-Jigani Link Road, Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 26, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
11 drug inspections on record since 2009: 2 with no problems, 8 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Adalimumab and Isopropyl Alcohol | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-016, 83257-017, 83257-019 |
| Denosumab | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-029, 83257-030 |
| Liraglutide | Makes it and tests it | Biocon Pharma Inc. | 70377-094, 70377-095 |
| Pegfilgrastim | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-005 |
| Simvastatin | Makes the active ingredient | Biocon Limited | 65727-065, 65727-066, 65727-067 +2 |
| Trastuzumab | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-001, 83257-003, 83257-004 |
| Ustekinumab | Makes it, tests it and packages it | Biocon Biologics Inc. | 83257-023, 83257-024, 83257-025 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 26, 2022 | Serious problems, FDA action | Drug Quality Assurance | — |
| Aug 30, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| May 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 29, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 19, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 13, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 29, 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.
Aug 30, 2019 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. - Theoretical yield statement including percentages 21 CFR 211.186(b)(7)
Master production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Registered with FDA for: analysis; manufacture; pack.