Drug factory · FDA FEI 3005497507
Unichem Laboratories Limited
Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 15, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbamazepine | Makes it, tests it, packages it and labels it | Unichem Pharmaceuticals (USA), Inc. | 29300-382 |
| Meloxicam | Makes it | New Horizon Rx Group, LLC | 58517-260 |
| Metformin | Makes it, tests it, packages it and labels it | Unichem Pharmaceuticals (USA), Inc. | 29300-389, 29300-399 |
| Methenamine | Makes it and packages it | Jubilant Cadista Pharmaceuticals Inc. | 59746-797 |
| Metronidazole | Makes it, tests it and packages it | BluePoint Laboratories. | 68001-364, 68001-365 |
| Quetiapine | Makes it, tests it, packages it and labels it | BluePoint Laboratories., Unichem Pharmaceuticals (USA), Inc. | 68001-598, 68001-599, 68001-600 +7 |
| Ranolazine | Makes it, tests it, packages it and labels it | Unichem Pharmaceuticals (USA), Inc. | 29300-296, 29300-297 |
| Valproic Acid | Makes it, tests it and packages it | BluePoint Laboratories. | 68001-646, 68001-647 |
| Zonisamide | Makes it, tests it, packages it and labels it | Unichem Pharmaceuticals (USA), Inc. | 29300-428, 29300-429, 29300-430 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 15, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jan 12, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 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.
Jul 15, 2024 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack.