Overview
- 25 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-22.
At a glance
Inspections
25
Form 483s
7
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2026 – 22 Jun 2026 | Medical Devices & Rad Health | Clean | |
| 12 Aug 2024 – 30 Aug 2024 | Human Drugs | 483 | View 483 → |
| 12 Sep 2022 – 15 Sep 2022 | Human Drugs | Clean | |
| 22 Oct 2019 – 24 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 19 Sep 2018 – 24 Sep 2018 | Human Drugs | Clean | |
| 24 Jul 2017 – 4 Aug 2017 | Human Drugs | 483 | View 483 → |
| 16 May 2016 – 23 May 2016 | Human Drugs | 483 | On file |
| 25 Jan 2016 – 28 Jan 2016 | Medical Devices & Rad Health | Clean | |
| 23 Apr 2015 – 1 May 2015 | Human Drugs | Clean | |
| 2 Sep 2014 – 8 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 14 Jul 2014 – 24 Jul 2014 | Human Drugs | 483 | On file |
| 12 Aug 2013 – 20 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Margaret M Annes, Shanna N Purdy, Kevin T Nguyen, Clinton J Lott
30 Aug 2024
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Margaret M Annes, Shanna N Purdy, Kevin T Nguyen, Clinton J Lott
30 Aug 2024
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Margaret M Annes, Shanna N Purdy, Kevin T Nguyen, Clinton J Lott
4 Aug 2017
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Shawn E Larson, Margaret M Annes
4 Aug 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Shawn E Larson, Margaret M Annes
Investigators
FDA investigators tied to this site in the record.
Margaret M Annes3 insp.
Travis M Beard2 insp.
Hala L Selby2 insp.
Iris C Macinnes2 insp.
Joel Martinez2 insp.
Charles D Brown2 insp.
Anh Lac2 insp.
David M Beltran2 insp.
Elizabeth A Krolczyk1 insp.
Katherine M Thames1 insp.
Shanna N Purdy1 insp.
Kevin T Nguyen1 insp.
Clinton J Lott1 insp.
Habacuc V Barrera1 insp.
Patty P Kaewussdangkul1 insp.
Shawn E Larson1 insp.
Theresa Kirkham1 insp.
Brian J Ryan1 insp.
Leighton K Ngai1 insp.
Rebecca Rodriguez1 insp.
Stephen D Brown1 insp.
Jeremy W Rotton1 insp.
Saijal Naik1 insp.
Torrance J Slayton1 insp.
Karen C Daugherty1 insp.
Rhonda L Dash1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alcon Research LLC's 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat