FDA Inspection 1270811 — Acino Products, LLC
The FDA completed an inspection of Acino Products, LLC on May 21, 2025 in Hamilton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hamilton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |