Janssen Ortho LLC
Form 483 issued February 22, 2013 · Gurabo, Puerto Rico
- Inspection
- Jan 17 – Feb 22, 2013
- Investigator
- Libia M. Lugo
- Observations
- 4
- Pages
- 4
- FEI number
- 3002942061
In short: On February 22, 2013, FDA issued a Form 483 with 4 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran Jan 17 – Feb 22, 2013. The investigator was Libia M. Lugo. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 2 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
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 314.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Ortho LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Libia M. Lugo is named on this Form 483, for the inspection of Jan 17 – Feb 22, 2013. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran Jan 17 – Feb 22, 2013, and the Form 483 is dated February 22, 2013.
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.