Drug factory · FDA FEI 3014086465
Biocon Generics Inc
1 Duncan Drive, Cranbury, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 10, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2022: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pravastatin | Makes it | Biocon Pharma Inc. | 70377-045, 70377-046, 70377-047 +1 |
| Triamterene | Makes it | Biocon Pharma Inc. | 70377-138, 70377-139 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 10, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 2, 2022 | 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.
Oct 10, 2025 inspection
- Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed.
Registered with FDA for: analysis; manufacture; pack.