Alcon Research LLC
Form 483 issued July 24, 2014 · Fort Worth, Texas
- Inspection
- Jul 14 – Jul 24, 2014
- Investigator
- Joel Martinez
- Observations
- 3
- Pages
- 2
- FEI number
- 1610287
In short: On July 24, 2014, FDA issued a Form 483 with 3 observations to Alcon Research LLC in Fort Worth, Texas (FEI 1610287) after an inspection that ran Jul 14 – Jul 24, 2014. The investigator was Joel Martinez. Most observations concern gLP.
At a glance
3 of 3 observations on this 483 concern glp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 58.90
Standard operating procedures for the housing, feeding, hand! ing, and care of…
- 02
The study director failed to assure that all experimental data, including observations of unanticipated responses of…
- 0321 CFR 58.107
Procedures have not been established for the handling of the test and control articles to ensure…
This inspection in context
Joel Martinez
7 documents · 2002–2014
Cites 211.80(a) (general requirements) 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 58.33
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcon Research LLC?
FDA listed 3 observations on this Form 483, mostly about gLP. The opening words of each observation are shown on this page.
Who inspected Alcon Research LLC?
Joel Martinez is named on this Form 483, for the inspection of Jul 14 – Jul 24, 2014. Each investigator has a profile showing what they cite most.
When was Alcon Research LLC inspected by FDA?
The inspection ran Jul 14 – Jul 24, 2014, and the Form 483 is dated July 24, 2014.
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.