FDA Inspection 1252181 — Galephar Pharmaceutical Research Inc.
The FDA completed an inspection of Galephar Pharmaceutical Research Inc. on Oct 18, 2024 in Juncos, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 18, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Juncos, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |