Drug factory · FDA FEI 3017224277
Stira Pharmaceuticals LLC
161 Dwight PI, Fairfield, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 6, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dimethyl Sulfoxide | Makes it | Renova Pharmaceuticals LLC | 84897-052 |
| Glutamine | Makes it, tests it and packages it | Renova Pharmaceuticals LLC | 84897-057 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 5, 2021 | 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.
Apr 6, 2026 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; manufacture; pack.