Drug factory · FDA FEI 3000233845
Nelson Laboratories, LLC
6280 South Redwood Road, Salt Lake City, UT, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 2, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 2, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 30, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 26, 2016 | No problems found | Drug Quality Assurance | 1 |
| Jan 10, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 9, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 8, 2010 | Problems found, fixed voluntarily | 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.
Jun 2, 2023 inspection
- Test methods 21 CFR 211.165(e)
The accuracy and sensitivity of test methods have not been established.
Feb 26, 2016 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications , standards , sampling plans and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
Registered with FDA for: analysis.