Janssen Biotech, Inc.
Form 483 issued March 5, 2018 · Malvern, Pennsylvania
- Inspection
- Feb 21 – Mar 5, 2018
- Investigator
- Anita R. Michael
- Observations
- 1
- Pages
- 1
- FEI number
- 3001610451
In short: On March 5, 2018, FDA issued a Form 483 with 1 observation to Janssen Biotech, Inc. in Malvern, Pennsylvania (FEI 3001610451) after an inspection that ran Feb 21 – Mar 5, 2018. The investigator was Anita R. Michael. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of the batch or any of it's components to…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmJanssen Biotech, 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 Janssen Biotech, 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 Janssen Biotech, Inc.?
Anita R. Michael is named on this Form 483, for the inspection of Feb 21 – Mar 5, 2018. Each investigator has a profile showing what they cite most.
When was Janssen Biotech, Inc. inspected by FDA?
The inspection ran Feb 21 – Mar 5, 2018, and the Form 483 is dated March 5, 2018.
How do I get the full Form 483 for Janssen Biotech, 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.