Drug factory · FDA FEI 3007503037
Resilience Biotechnologies, Inc.
2585 Meadowpine Blvd., Mississauga, Canada
Problems found, fixed voluntarily at FDA's last inspection, Nov 10, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amikacin | Makes it and tests it | Insmed Incorporated | 71558-590 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 28, 2019 | 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.
Nov 10, 2023 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - 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.
Registered with FDA for: analysis; api manufacture; manufacture; pack.