Drug factory · FDA FEI 3003516812
Patheon Inc.
111 Consumers Drive, Whitby, Canada
Problems found, fixed voluntarily at FDA's last inspection, Feb 17, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 3 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 |
|---|---|---|---|
| Feb 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Dec 9, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 4, 2014 | No problems found | Drug Quality Assurance | — |
| May 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 7, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 27, 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.
Feb 17, 2023 inspection
- Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Sep 14, 2018 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation. - Component identity verification 21 CFR 211.84(d)(1)
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Registered with FDA for: analysis; label; manufacture; pack.