Genus Lifesciences Inc.
Form 483 issued December 13, 2024 · Allentown, Pennsylvania
- Inspection
- Dec 9 – Dec 13, 2024
- Investigators
- Azeezat M. Lawal· Evan Tong
- Observations
- 1
- Pages
- 3
- FEI number
- 3014677161
In short: On December 13, 2024, FDA issued a Form 483 with 1 observation to Genus Lifesciences Inc. in Allentown, Pennsylvania (FEI 3014677161) after an inspection that ran Dec 9 – Dec 13, 2024. The investigators were Azeezat M. Lawal and Evan Tong. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmGenus Lifesciences Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genus Lifesciences Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Genus Lifesciences Inc.?
Azeezat M. Lawal and Evan Tong are named on this Form 483, for the inspection of Dec 9 – Dec 13, 2024. Each investigator has a profile showing what they cite most.
When was Genus Lifesciences Inc. inspected by FDA?
The inspection ran Dec 9 – Dec 13, 2024, and the Form 483 is dated December 13, 2024.
How do I get the full Form 483 for Genus Lifesciences Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.