Drug factory · FDA FEI 1047293
USAntibiotics, LLC
201 Industrial Drive, Bristol, TN, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 4, 2025.
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 2011: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amoxicillin | Makes it and packages it | USAntibiotics, LLC | 81964-205, 81964-207, 81964-225 +1 |
| Amoxicillin and Clavulanic Acid | Makes it, tests it and packages it | USAntibiotics, LLC | 81964-003, 81964-203, 81964-204 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 4, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 17, 2024 | No problems found | Bioresearch Monitoring | — |
| Dec 13, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 9, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 22, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 3, 2011 | 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.
Apr 4, 2025 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed. - Systems in place to comply with verification requirements FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Registered with FDA for: analysis; manufacture; pack.