FDA Inspection 1266937 — Ailex Pharmaceuticals LLC
The FDA completed an inspection of Ailex Pharmaceuticals LLC on Apr 16, 2025 in Lenexa, KS. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lenexa, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |