Alcon Research LLC
Form 483 issued August 4, 2017 · Fort Worth, Texas
- Inspection
- Jul 24 – Aug 4, 2017
- Investigators
- Margaret M. Annes· Shawn E. Larson
- Observations
- 2
- Pages
- 2
- FEI number
- 1610287
In short: On August 4, 2017, FDA issued a Form 483 with 2 observations to Alcon Research LLC in Fort Worth, Texas (FEI 1610287) after an inspection that ran Jul 24 – Aug 4, 2017. The investigators were Margaret M. Annes and Shawn E. Larson. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcon Research LLC?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Alcon Research LLC?
Margaret M. Annes and Shawn E. Larson are named on this Form 483, for the inspection of Jul 24 – Aug 4, 2017. Each investigator has a profile showing what they cite most.
When was Alcon Research LLC inspected by FDA?
The inspection ran Jul 24 – Aug 4, 2017, and the Form 483 is dated August 4, 2017.
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.