Janssen Ortho LLC
Form 483 issued August 28, 2018 · Gurabo, Puerto Rico
- Inspection
- Aug 6 – Aug 28, 2018
- Investigators
- Libia M. Lugo· Raquel Gonzalez Rivera
- Observations
- 3
- Pages
- 10
- FEI number
- 3002942061
In short: On August 28, 2018, FDA issued a Form 483 with 3 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran Aug 6 – Aug 28, 2018. The investigators were Libia M. Lugo and Raquel Gonzalez Rivera. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Batch production and control records do not include the results of any investigation made into any…
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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Ortho LLC?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Libia M. Lugo and Raquel Gonzalez Rivera are named on this Form 483, for the inspection of Aug 6 – Aug 28, 2018. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran Aug 6 – Aug 28, 2018, and the Form 483 is dated August 28, 2018.
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.