FDA Inspection 604755 — Denison Pharmaceuticals, LLC
The FDA completed an inspection of Denison Pharmaceuticals, LLC on August 5, 2009 in Lincoln, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2009
- Fiscal Year
- 2009
- 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 |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |