FDA Inspection 1196871 — Denison Pharmaceuticals, LLC
The FDA completed an inspection of Denison Pharmaceuticals, LLC on February 9, 2023 in Lincoln, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 9, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lincoln, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |