Allergan Sales, LLC
Form 483 issued July 9, 2010 · Irvine, California
- Inspection
- Jul 6 – Jul 9, 2010
- Investigator
- Binh T. Nguyen
- Observations
- 3
- Pages
- 7
- FEI number
- 2011068
In short: On July 9, 2010, FDA issued a Form 483 with 3 observations to Allergan Sales, LLC in Irvine, California (FEI 2011068) after an inspection that ran Jul 6 – Jul 9, 2010. The investigator was Binh T. Nguyen. 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
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
Specifically, the following) periodic adverse drug experience…
- 03
An annual report was not submitted within 60 days of the) ——_—_date of U.S. approval of…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAllergan Sales, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80(c)(1)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Sales, 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 Allergan Sales, LLC?
Binh T. Nguyen is named on this Form 483, for the inspection of Jul 6 – Jul 9, 2010. Each investigator has a profile showing what they cite most.
When was Allergan Sales, LLC inspected by FDA?
The inspection ran Jul 6 – Jul 9, 2010, and the Form 483 is dated July 9, 2010.
How do I get the full Form 483 for Allergan Sales, 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.