Drug factory · FDA FEI 3002807186
Bausch Health Companies Inc.
2150 boul Saint-Elzear O, Laval, Canada
No problems found at FDA's last inspection, Jan 19, 2024.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2008: 4 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 19, 2024 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2022 | No problems found | Drug Quality Assurance | — |
| Sep 19, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 17, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2008 | 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.
Sep 20, 2013 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack.