Drug factory · FDA FEI 3008763868
Beximco Pharmaceuticals PLC
126, Kathaldia, Tongi, Bangladesh
Problems found, fixed voluntarily at FDA's last inspection, Mar 30, 2023.
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 2015: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carvedilol | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-110, 76385-111, 76385-112 +1 |
| Cyproheptadine | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-130 |
| Eletriptan | Makes it | Apnar Pharma LP | 24689-167, 24689-168 |
| Flecainide | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-145, 76385-146, 76385-147 |
| Metformin | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-128, 76385-129 |
| Methocarbamol | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-123, 76385-124 |
| Nadolol | Makes it, tests it and packages it | BluePoint Laboratories., Unichem Pharmaceuticals (USA), Inc. | 68001-630, 68001-631, 68001-632 +3 |
| Nebivolol | Makes it | Apnar Pharma LP | 24689-159, 24689-160, 24689-161 +1 |
| Sotalol | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-114, 76385-115, 76385-116 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 30, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 22, 2015 | No problems found | 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.
Mar 30, 2023 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
Registered with FDA for: analysis; manufacture; pack.