Drug factory · FDA FEI 3008861619
Centaur Pharmaceuticals Private Limited
Plot no. 4, International Biotech Park, Phase-II, Hinjewadi, Pune, India
Serious problems, FDA action at FDA's last inspection, Feb 8, 2023.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
5 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alprazolam | Makes it, tests it and packages it | Breckenridge Pharmaceutical, Inc. | 51991-704, 51991-705, 51991-706 +1 |
| Amitriptyline | Makes it, tests it and packages it | Centaur Pharmaceuticals Private Limited | 64330-630, 64330-631, 64330-632 +3 |
| Asenapine | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-358, 51991-359, 51991-360 +2 |
| Cabergoline | Makes it, tests it and packages it | Ingenus Pharmaceuticals, LLC | 50742-118 |
| Lamivudine | Makes it, tests it and packages it | Centaur Pharmaceuticals Private Limited | 64330-001 |
| Metolazone | Makes it, tests it and packages it | Unichem Pharmaceuticals (USA), Inc. | 76385-136, 76385-137, 76385-138 |
| Milnacipran | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-034, 51991-036, 51991-037 +1 |
| Pindolol | Makes it, tests it and packages it | Unichem Pharmaceuticals (USA), Inc. | 76385-131, 76385-132 |
| Pyridostigmine | Makes it, tests it and packages it | Rising Pharma Holdings, Inc. | 64980-220 |
| Zolpidem | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-981, 51991-982 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 8, 2023 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 13, 2019 | No problems found | Drug Quality Assurance | — |
| Nov 14, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 27, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 19, 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.
Nov 14, 2016 inspection
- Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
Registered with FDA for: analysis; manufacture; pack.