Alcon Research LLC
Form 483 issued May 23, 2016 · Fort Worth, Texas
- Investigator
- Jamillah Selby
- Observations
- 1
- Pages
- 2
- FEI number
- 1610287
In short: On May 23, 2016, FDA issued a Form 483 with 1 observation to Alcon Research LLC in Fort Worth, Texas (FEI 1610287). The investigator was Jamillah Selby. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Periodic adverse drug experience reports were not submitted within thirty working days of the close of…
This inspection in context
Jamillah Selby
7 documents · 2013–2024
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmAlcon Research LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcon Research LLC?
FDA listed 1 observation 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 Alcon Research LLC?
Jamillah Selby is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Alcon Research LLC inspected by FDA?
This Form 483 is dated May 23, 2016.
How do I get the full Form 483 for Alcon Research 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.