Drug factory · FDA FEI 3002806578
Pharmascience Inc.
100 Boulevard de L'industrie, Candiac, Canada
Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bortezomib | Makes it | Pharmascience Inc. | 51817-586 |
| Busulfan | Makes it | Pharmascience Inc. | 51817-170 |
| Ganciclovir | Makes it | Pharmascience Inc. | 51817-171 |
| Methotrexate | Makes it | Antares Pharma, Inc. | 54436-010, 54436-012, 54436-015 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 13, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 5, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 17, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2010 | 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.
Feb 13, 2024 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Registered with FDA for: analysis; label; manufacture; pack.