Company
United StatesGenus Lifesciences Inc., Allentown, PA – FDA Inspections
Inspection records and compliance data for Genus Lifesciences Inc. in Allentown, Pennsylvania. 11 FDA inspections on record (1 OAI), 3 Form 483s, last inspected July 31, 2024.
Company Profile
This profile covers Genus Lifesciences Inc. based in Allentown, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 1
- VAI
- 5
- NAI
- 5
- Form 483s
- 3
- Warning letters
- 0
First inspected July 7, 2009. Last inspected July 31, 2024.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Contamination, chemical or physical change, deterioration2 inspections
- Investigations of discrepancies, failures2 inspections
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 31, 2024 | NAI | Human Drugs · Drug Quality Assurance | 1245779 |
| September 20, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1102370 |
| November 28, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1073444 |
| July 20, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1059468 |
| September 29, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1027671 |
| August 11, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 982555 |
| October 17, 2014 | VAI | Human Drugs · Drug Quality Assurance | 904539 |
| December 5, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 809490 |
| December 8, 2011 | NAI | Human Drugs · Drug Quality Assurance | 758947 |
| February 3, 2011 | OAI | Human Drugs · Drug Quality Assurance | 710247 |
| July 7, 2009 | VAI | Human Drugs · Drug Quality Assurance | 595677 |
FDA documents
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Company Information
Name
Genus Lifesciences Inc.
FEI Number
3003851100
Address
514 N 12th St, Allentown, Pennsylvania 18102, United States
Country
United States
ID: ba29ccf4-c220-4a87-ab2e-cd37322d0957