Drug factory · FDA FEI 3014677161
Genus Lifesciences Inc.
700 North Fenwick Street, Allentown, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2024.
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 2021: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrocodone and Methylhomatropine | Makes it | Genus Lifesciences Inc. | 64950-206 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 13, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 23, 2021 | 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.
Dec 13, 2024 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and 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: label; manufacture; pack.