Janssen Biologics B.V.
Form 483 issued July 11, 2014 · Leiden, Netherlands
- Inspection
- Jul 7 – Jul 11, 2014
- Investigator
- Patric C. Klotzbuecher
- Observations
- 1
- Pages
- 2
- FEI number
- 3002806632
In short: On July 11, 2014, FDA issued a Form 483 with 1 observation to Janssen Biologics B.V. in Leiden, Netherlands (FEI 3002806632) after an inspection that ran Jul 7 – Jul 11, 2014. The investigator was Patric C. Klotzbuecher. 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
Investigations of a failure of a batch or any of its components to meet any of…
This inspection in context
Patric C. Klotzbuecher
13 documents · 2014–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmJanssen Biologics B.V. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Biologics B.V.?
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 Biologics B.V.?
Patric C. Klotzbuecher is named on this Form 483, for the inspection of Jul 7 – Jul 11, 2014. Each investigator has a profile showing what they cite most.
When was Janssen Biologics B.V. inspected by FDA?
The inspection ran Jul 7 – Jul 11, 2014, and the Form 483 is dated July 11, 2014.
How do I get the full Form 483 for Janssen Biologics B.V.?
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.