Drug factory · FDA FEI 3002807812
Element Materials Technology Life Sciences Canada, Inc.
2599 Speakman Drive, Suite 200, 210, Mississauga, Canada
Problems found, fixed voluntarily at FDA's last inspection, Jan 22, 2025.
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: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxcarbazepine | Tests it | Ajanta Pharma USA Inc. | 27241-304, 27241-305, 27241-306 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 9, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 29, 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.
Oct 18, 2019 inspection
- Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards. - 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.
Feb 9, 2015 inspection
- Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred.
Registered with FDA for: analysis.