Janssen Pharmaceuticals, Inc.
Form 483 issued January 24, 2025 · Athens, Georgia
- Inspection
- Jan 22 – Jan 24, 2025
- Investigator
- Kara J. Wright
- Observations
- 13
- Pages
- 37
- FEI number
- 1033845
In short: On January 24, 2025, FDA issued a Form 483 with 13 observations to Janssen Pharmaceuticals, Inc. in Athens, Georgia (FEI 1033845) after an inspection that ran Jan 22 – Jan 24, 2025. The investigator was Kara J. Wright. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Raw material receipt sampling method is not adequate. Sampling controls do not include scientifically sound sampling…
This inspection in context
Kara J. Wright
9 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmJanssen Pharmaceuticals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Pharmaceuticals, Inc.?
FDA listed 13 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Janssen Pharmaceuticals, Inc.?
Kara J. Wright is named on this Form 483, for the inspection of Jan 22 – Jan 24, 2025. Each investigator has a profile showing what they cite most.
When was Janssen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 22 – Jan 24, 2025, and the Form 483 is dated January 24, 2025.
How do I get the full Form 483 for Janssen Pharmaceuticals, 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.