Drug factory · FDA FEI 3009856628
Halo Pharmaceutical Canada, Inc
17800 Lapointe, Mirabel, Canada
No problems found at FDA's last inspection, Feb 17, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2014: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atorvastatin | Makes it | Agnitio Inc., August Pharmaceutical, LLC | 72134-009, 72134-010, 72134-011 +5 |
| Betamethasone | Makes it, tests it, packages it and labels it | TruPharma LLC. | 52817-824 |
| Dapsone | Makes it, tests it and packages it | Cosette Pharmaceuticals, Inc. | 0713-0886 |
| Dextromethorphan and Promethazine | Makes it, tests it, packages it and labels it | Xttrium Laboratories, Inc. | 0116-4024 |
| Indomethacin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-2086 |
| Promethazine | Makes it, tests it, packages it and labels it | Xttrium Laboratories, Inc. | 0116-4023 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 17, 2023 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.