FDA Inspection 1262179 — Advance Pharmaceutical Inc
The FDA completed an inspection of Advance Pharmaceutical Inc on Feb 27, 2025 in Holtsville, NY. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 27, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holtsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1409 | 21 CFR 211.42(c)(4) | In-Process Material Area |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |