Janssen Ortho LLC
Form 483 issued May 18, 2016 · Gurabo, Puerto Rico
- Inspection
- May 11 – May 18, 2016
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 1
- Pages
- 2
- FEI number
- 3002942061
In short: On May 18, 2016, FDA issued a Form 483 with 1 observation to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran May 11 – May 18, 2016. The investigator was Laurimer Kuilan-Torres. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmJanssen Ortho LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Ortho LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of May 11 – May 18, 2016. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran May 11 – May 18, 2016, and the Form 483 is dated May 18, 2016.
How do I get the full Form 483 for Janssen Ortho LLC?
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.