Janssen Ortho LLC
Form 483 issued June 13, 2011 · Gurabo, Puerto Rico
- Inspection
- Jun 6 – Jun 13, 2011
- Investigator
- Ramon A. Hernandez
- Observations
- 2
- Pages
- 2
- FEI number
- 3002942061
In short: On June 13, 2011, FDA issued a Form 483 with 2 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran Jun 6 – Jun 13, 2011. The investigator was Ramon A. Hernandez. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Ramon A. Hernandez
2 documents · 2010–2011
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in Maryland.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Ortho LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. 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 Ortho LLC?
Ramon A. Hernandez is named on this Form 483, for the inspection of Jun 6 – Jun 13, 2011. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran Jun 6 – Jun 13, 2011, and the Form 483 is dated June 13, 2011.
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.