FDA Inspection 1291594 — Marlex Pharmaceuticals, Inc.
The FDA completed an inspection of Marlex Pharmaceuticals, Inc. on November 14, 2025 in New Castle, DE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Castle, DE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |