Drug factory · FDA FEI 3002808342
E-Z-EM Canada Inc
11065 L.H. Lafontaine Blvd, Anjou, Canada
Problems found, fixed voluntarily at FDA's last inspection, Oct 20, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Barium | Makes it, tests it, packages it and labels it | E-Z-EM Canada Inc, E-Z-Em, Inc. | 32909-105, 32909-115, 32909-116 +20 |
| Diatrizoic Acid | Makes it and tests it | Bracco Diagnostics Inc. | 0270-0445 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 7, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2011 | 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 20, 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. - 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.