Actavis Elizabeth LLC
Form 483 issued February 15, 2017 · Elizabeth, New Jersey
- Inspection
- Jan 23 – Feb 15, 2017
- Investigators
- Guerlain Ulysse· Sachinkumar V. Patel· Yvesna Blaise
- Observations
- 1
- Pages
- 2
- FEI number
- 2211563
In short: On February 15, 2017, FDA issued a Form 483 with 1 observation to Actavis Elizabeth LLC in Elizabeth, New Jersey (FEI 2211563) after an inspection that ran Jan 23 – Feb 15, 2017. The investigators were Guerlain Ulysse, Sachinkumar V. Patel and Yvesna Blaise. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmActavis Elizabeth LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Actavis Elizabeth LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Actavis Elizabeth LLC?
Guerlain Ulysse, Sachinkumar V. Patel and Yvesna Blaise are named on this Form 483, for the inspection of Jan 23 – Feb 15, 2017. Each investigator has a profile showing what they cite most.
When was Actavis Elizabeth LLC inspected by FDA?
The inspection ran Jan 23 – Feb 15, 2017, and the Form 483 is dated February 15, 2017.
How do I get the full Form 483 for Actavis Elizabeth LLC?
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