Alcon Research LLC
Form 483 issued August 30, 2024 · Fort Worth, Texas
- Inspection
- Aug 12 – Aug 30, 2024
- Investigators
- Clinton J. Lott· Kevin T. Nguyen
- Observations
- 3
- Pages
- 42
- FEI number
- 1610287
In short: On August 30, 2024, FDA issued a Form 483 with 3 observations to Alcon Research LLC in Fort Worth, Texas (FEI 1610287) after an inspection that ran Aug 12 – Aug 30, 2024. The investigators were Clinton J. Lott and Kevin T. Nguyen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.58 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Your firm failed to have systems in place to enable compliance with the verification…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.58
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 facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Alcon Research LLC?
Clinton J. Lott and Kevin T. Nguyen are named on this Form 483, for the inspection of Aug 12 – Aug 30, 2024. Each investigator has a profile showing what they cite most.
When was Alcon Research LLC inspected by FDA?
The inspection ran Aug 12 – Aug 30, 2024, and the Form 483 is dated August 30, 2024.
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.