Genus Lifesciences Inc.
Form 483 issued September 20, 2019 · Allentown, Pennsylvania
- Inspection
- Sep 9 – Sep 20, 2019
- Investigator
- David A. Oluwo
- Observations
- 3
- Pages
- 3
- FEI number
- 3003851100
In short: On September 20, 2019, FDA issued a Form 483 with 3 observations to Genus Lifesciences Inc. in Allentown, Pennsylvania (FEI 3003851100) after an inspection that ran Sep 9 – Sep 20, 2019. The investigator was David A. Oluwo. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
An ND A-Field Alert Report was not submitted within three working days of receipt of information…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) 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 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Genus Lifesciences Inc.?
David A. Oluwo is named on this Form 483, for the inspection of Sep 9 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Genus Lifesciences Inc. inspected by FDA?
The inspection ran Sep 9 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
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.