Janssen Ortho LLC
Form 483 issued May 29, 2015 · Gurabo, Puerto Rico
- Inspection
- May 26 – May 29, 2015
- Investigators
- Ariel Cruz Figueroa· Binh T. Nguyen· Dennis Cantellops Paite
- Observations
- 3
- Pages
- 5
- FEI number
- 3002942061
In short: On May 29, 2015, FDA issued a Form 483 with 3 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran May 26 – May 29, 2015. The investigators were Ariel Cruz Figueroa, Binh T. Nguyen, Dennis Cantellops Paite, Laurimer Kuilan-Torres and Vilmary Negron Rodriguez. Most observations concern laboratory controls and packaging & labeling; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The results of the examination of the packaged and labeled products were not documented in the…
- 02
Samples taken of drug products for determination of conformance to written…
- 03
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) 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 211.134(c)
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 laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Ariel Cruz Figueroa, Binh T. Nguyen, Dennis Cantellops Paite, Laurimer Kuilan-Torres and Vilmary Negron Rodriguez are named on this Form 483, for the inspection of May 26 – May 29, 2015. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran May 26 – May 29, 2015, and the Form 483 is dated May 29, 2015.
How do I get the full Form 483 for Janssen Ortho LLC?
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