Genus Lifesciences Inc.
Genus Lifesciences Inc. has 1 FDA recall, 13 inspections, 0 510(k) clearances and 3 compliance actions on record.
- Latest recall
- D-0231-2021 · Class III · Dec 23, 2020
- Latest inspection
- Dec 13, 2024 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 13 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0231-2021 | Class III | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc… | Dec 23, 2020 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 13, 2024 | Allentown, PA | Drugs | Voluntary Action Indicated (VAI) | 3014677161 |
| Jul 31, 2024 | Allentown, PA | Drugs | No Action Indicated (NAI) | 3003851100 |
| Jul 23, 2021 | Allentown, PA | Drugs | No Action Indicated (NAI) | 3014677161 |
| Sep 20, 2019 | Allentown, PA | Drugs | Voluntary Action Indicated (VAI) | 3003851100 |
| Nov 28, 2018 | Allentown, PA | Drugs | No Action Indicated (NAI) | 3003851100 |
| Jul 20, 2018 | Allentown, PA | Drugs | Voluntary Action Indicated (VAI) | 3003851100 |
| Sep 29, 2017 | Allentown, PA | Drugs | Voluntary Action Indicated (VAI) | 3003851100 |
| Aug 11, 2016 | Allentown, PA | Drugs | No Action Indicated (NAI) | 3003851100 |
| Oct 17, 2014 | Allentown, PA | Drugs | Voluntary Action Indicated (VAI) | 3003851100 |
| Dec 5, 2012 | Allentown, PA | Drugs | No Action Indicated (NAI) | 3003851100 |
| Dec 8, 2011 | Allentown, PA | Drugs | No Action Indicated (NAI) | 3003851100 |
| Feb 3, 2011 | Allentown, PA | Drugs | Official Action Indicated (OAI) | 3003851100 |
| Jul 7, 2009 | Allentown, PA | Drugs | Voluntary Action Indicated (VAI) | 3003851100 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 3 compliance actions under Genus Lifesciences Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3014677161 | Allentown, PA | 2 | Dec 13, 2024 |
| FEI 3003851100 | Allentown, PA | 11 | Jul 31, 2024 |
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