Drug factory · FDA FEI 3021614574
Waylis Therapeutics
2131 Felver Court Suite B, Rahway, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 12, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2026: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Flutamide | Labels it | Waylis Therapeutics LLC | 80725-600 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 12, 2026 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 12, 2026 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance of post marketing adverse drug experiences.
Registered with FDA for: label; manufacture.