Genus Lifesciences Inc. — FDA Facility Profile
Genus Lifesciences Inc. is an FDA-registered facility (FEI 3003851100) located in Allentown, PA, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 11 FDA inspections and 3 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Jul 31, 2024: No Action Indicated (NAI)
- Inspections on record
- 11 (1 OAI, 5 VAI, 5 NAI)
- Last OAI inspection
- Feb 3, 2011
- Warning letters
- 3 listed by FDA for this FEI, latest Jul 15, 2011
- Recalls as the recalling firm
- 1, latest Dec 23, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 31, 2024 | No Action Indicated (NAI) | No citations listed |
| Sep 20, 2019 | Voluntary Action Indicated (VAI) | Absence of Written Procedures (21 CFR 211.100(a)) Investigations of discrepancies, failures (21 CFR 211.192) Contamination, chemical or physical change, deterioration (21 CFR 314.81(b)(1)(ii)) |
| Nov 28, 2018 | No Action Indicated (NAI) | No citations listed |
| Jul 20, 2018 | Voluntary Action Indicated (VAI) | Component identity verification (21 CFR 211.84(d)(1)) Establish reliability of supplier's C of A (21 CFR 211.84(d)(3)) Failing drug products not rejected (21 CFR 211.165(f)) Investigations of discrepancies, failures (21 CFR 211.192) and 1 more |
| Sep 29, 2017 | Voluntary Action Indicated (VAI) | Computer control of master formula records (21 CFR 211.68(b)) Complete test data included in records (21 CFR 211.194(a)) |
| Aug 11, 2016 | No Action Indicated (NAI) | No citations listed |
| Oct 17, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 5, 2012 | No Action Indicated (NAI) | No citations listed |
| Dec 8, 2011 | No Action Indicated (NAI) | No citations listed |
| Feb 3, 2011 | Official Action Indicated (OAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Absence of Written Procedures (21 CFR 211.100(a)) Testing and release for distribution (21 CFR 211.165(a)) Procedure Deviations Recorded and Justified (21 CFR 211.100(b)) and 1 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Dec 23, 2020 | Class III | D-0231-2021 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus… Presence of Foreign Substance: Particulate matter was found in multiple lots of product. |
Facility details
- Company
- Genus Lifesciences Inc.
- Location
- Allentown, PA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs