Drug factory · FDA FEI 3009003838
Jubilant DraxImage Inc., dba Jubilant Radiopharma
16751 Trans Canada Highway, Kirkland, Canada
Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2013: 1 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 |
|---|---|---|---|
| Apr 23, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 8, 2017 | No problems found | Drug Quality Assurance | — |
| Dec 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 17, 2013 | 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.
Jun 10, 2022 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 drug products 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. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Dec 17, 2015 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review 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. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies.
Registered with FDA for: analysis; label; manufacture; pack.