FDA Inspection 891224 — Acino Products, LLC
The FDA completed an inspection of Acino Products, LLC on August 19, 2014 in Hamilton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2014
- Fiscal Year
- 2014
- 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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |