Drug factory · FDA FEI 3011419064
Benuvia Operations, LLC
3950 N Mays St, Round Rock, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 23, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2017: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dronabinol | Makes it, makes the active ingredient, tests it, packages it and labels it | Wellhouse Pharma, LLC | 85776-202 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 23, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 20, 2021 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2017 | 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.
Jan 23, 2026 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - 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; api manufacture; label; manufacture; pack; repack.