Drug factory · FDA FEI 3001581899
Contract Pharmaceuticals Limited Canada
7600 Danbro Crescent, Mississauga, Canada
Problems found, fixed voluntarily at FDA's last inspection, Nov 3, 2023.
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: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acyclovir and Hydrocortisone | Makes it | Bausch Health US, LLC | 0187-5104 |
| Benzoyl Peroxide and Clindamycin | Makes it and packages it | Bausch Health US, LLC, Oceanside Pharmaceuticals. | 0187-3050, 13548-132, 68682-132 +1 |
| Capsaicin | Makes it | Averitas Pharma, Inc. | 72512-928, 72512-929, 72512-930 |
| Clindamycin and Tretinoin | Makes it and packages it | Bausch Health US, LLC, Oceanside Pharmaceuticals. | 99207-300, 68682-300 |
| Clobetasol | Makes it | Alembic Pharmaceuticals Inc. | 62332-425 |
| Difamilast | Makes it and packages it | Acrotech Biopharma Inc | 72893-017 |
| Permethrin | Makes it and labels it | Dr. Reddy's Laboratories Inc. | 43598-481 |
| Testosterone | Makes it | Alembic Pharmaceuticals Inc., Upsher-Smith Laboratories, Inc. | 62332-552, 0245-0871, 0245-0872 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 3, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 17, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 31, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 3, 2009 | 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.
Nov 3, 2023 inspection
- 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.
May 17, 2019 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Registered with FDA for: label; manufacture; pack.