FDA Inspection 732115 — Quadex Pharmaceuticals, Llc
The FDA completed an inspection of Quadex Pharmaceuticals, Llc on June 28, 2011 in South Jordan, UT. 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
- June 28, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Jordan, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 3641 | 21 CFR 211.204 | Record information inclusions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |