Janssen Biologics B.V.
Form 483 issued September 28, 2012 · Leiden, Netherlands
- Inspection
- Sep 20 – Sep 28, 2012
- Investigator
- Rebeca Rodriguez
- Observations
- 2
- Pages
- 1
- FEI number
- 3002806632
In short: On September 28, 2012, FDA issued a Form 483 with 2 observations to Janssen Biologics B.V. in Leiden, Netherlands (FEI 3002806632) after an inspection that ran Sep 20 – Sep 28, 2012. The investigator was Rebeca Rodriguez. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to conduct production operations in a manner that prevents microbial and endotoxin contamination…
- 02
The Quality Unit failed to ensure that complete investigations are conducted and that corrective/preventive actions are…
This inspection in context
Rebeca Rodriguez
6 documents · 2011–2015
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Biologics B.V.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Janssen Biologics B.V.?
Rebeca Rodriguez is named on this Form 483, for the inspection of Sep 20 – Sep 28, 2012. Each investigator has a profile showing what they cite most.
When was Janssen Biologics B.V. inspected by FDA?
The inspection ran Sep 20 – Sep 28, 2012, and the Form 483 is dated September 28, 2012.
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.