Actavis Elizabeth LLC
Form 483 issued April 26, 2011 · Elizabeth, New Jersey
- Inspection
- Apr 7 – Apr 26, 2011
- Investigators
- Erin D. McCaffery· Michael Serrano
- Observations
- 3
- Pages
- 3
- FEI number
- 2211563
In short: On April 26, 2011, FDA issued a Form 483 with 3 observations to Actavis Elizabeth LLC in Elizabeth, New Jersey (FEI 2211563) after an inspection that ran Apr 7 – Apr 26, 2011. The investigators were Erin D. McCaffery and Michael Serrano. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including…
- 02
Not all adverse drug expericuces that-are both serious and unexpevied have'been reported to FDA within 1%…
- 03
Written procedures have not been developed for the surveillance, receipt, and evaluation of post…
This inspection in context
Erin D. McCaffery
4 documents · 2008–2011
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New Jersey.
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 314.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Actavis Elizabeth LLC?
FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Actavis Elizabeth LLC?
Erin D. McCaffery and Michael Serrano are named on this Form 483, for the inspection of Apr 7 – Apr 26, 2011. Each investigator has a profile showing what they cite most.
When was Actavis Elizabeth LLC inspected by FDA?
The inspection ran Apr 7 – Apr 26, 2011, and the Form 483 is dated April 26, 2011.
How do I get the full Form 483 for Actavis Elizabeth 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.