Alcon Research LLC
FDA inspection history in Fort Worth, Texas, 2014 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2016: one Form 483; 2017: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Three Form 483s, at Fort Worth, Texas.
- 2024One Form 483, at Fort Worth, Texas.
- 2024The longest 483 on file: 3 observations over 42 pages at Fort Worth, Texas.
Cited most
Across all Alcon Research observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.58Maintenance1
- 21 CFR 314.80Postmarketing reporting of adverse drug experiences1
- 21 CFR 58.107Test and control article handling1
The complete Alcon Research file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fort Worth, Texas
Four Form 483s · 2014 to 2024 · 9 observations
Latest: Form 483, Aug 30, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-30 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
| 2017-08-04 | 483 Form 483 | Fort Worth, Texas | 2 | $99 |
| 2016-05-23 | 483 Form 483 | Fort Worth, Texas | 1 | $99 |
| 2014-07-24 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
Investigators on these documents
Clinton J. Lott (1)Jamillah Selby (1)Joel Martinez (1)Kevin T. Nguyen (1)Margaret M. Annes (1)Shawn E. Larson (1)
FEI number 1610287 · most recent document Aug 30, 2024
About Alcon Research LLC
How many FDA Form 483s has Alcon Research LLC received?
FDA Intel has 4 Form 483s on file for Alcon Research LLC; the most recent is dated Aug 30, 2024.
When was Alcon Research LLC last inspected by FDA?
The most recent FDA inspection document on file for Alcon Research LLC is a Form 483 dated Aug 30, 2024, for the site in Fort Worth, Texas.
What did FDA cite at Alcon Research LLC?
The regulations cited most in the observations on file for Alcon Research LLC are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.58 (Maintenance), 1 time.