FDA Inspection 1266720 — Pharmaloz Manufacturing Inc.
The FDA completed an inspection of Pharmaloz Manufacturing Inc. on April 14, 2025 in Lebanon, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lebanon, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |