FDA Inspection 1220590 — Apothecus Pharmaceutical Corp.
The FDA completed an inspection of Apothecus Pharmaceutical Corp. on Oct 6, 2023 in Hicksville, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 6, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hicksville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |