FDA Inspection 969790 — Denison Pharmaceuticals, LLC
The FDA completed an inspection of Denison Pharmaceuticals, LLC on April 5, 2016 in Lincoln, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Lincoln, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |