Drug factory · FDA FEI 1610287
Alcon Research LLC
6201 South Freeway, Fort Worth, TX, United States
No problems found at FDA's last inspection, Sep 15, 2022.
No Action Indicated: inspectors found no objectionable conditions.
12 drug inspections on record since 2009: 7 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 15, 2022 | No problems found | Bioresearch Monitoring | — |
| Sep 24, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 4, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 23, 2016 | No problems found | Bioresearch Monitoring | — |
| May 1, 2015 | No problems found | Drug Quality Assurance | — |
| May 8, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2013 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Mar 29, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 21, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| May 18, 2010 | No problems found | Drug Quality Assurance | — |
| May 18, 2010 | No problems found | Bioresearch Monitoring | — |
| Apr 24, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 4, 2017 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Oct 21, 2010 inspection
- Monitoring investigations 21 CFR 312.56(a)
Failure to monitor the progress of an investigation conducted under your IND.
Registered with FDA for: manufacture; relabel; repack.