Janssen Ortho LLC
Form 483 issued June 8, 2009 · Gurabo, Puerto Rico
- Inspection
- May 26 – Jun 8, 2009
- Investigator
- Jose E. Melendez
- Observations
- 2
- Pages
- 2
- FEI number
- 3002942061
In short: On June 8, 2009, FDA issued a Form 483 with 2 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran May 26 – Jun 8, 2009. The investigator was Jose E. Melendez. Most observations concern quality system and production.
At a glance
Quality system and production 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
Observation 1: scanned text, readable in the full document.
- 02
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 2 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Jose E. Melendez is named on this Form 483, for the inspection of May 26 – Jun 8, 2009. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran May 26 – Jun 8, 2009, and the Form 483 is dated June 8, 2009.
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.