Drug factory · FDA FEI 3007632373
SGS Canada Inc
6490 Vipond Dr, Mississauga, Canada
No problems found at FDA's last inspection, Nov 15, 2023.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 15, 2023 | No problems found | Drug Quality Assurance | — |
| Oct 16, 2019 | No problems found | Drug Quality Assurance | — |
| Dec 12, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 20, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 10, 2009 | 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.
Dec 12, 2017 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established specifications, standards and laboratory control mechanisms are 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.