FDA Inspection 612472 — Izeen Pharma Inc
The FDA completed an inspection of Izeen Pharma Inc on October 13, 2009 in Frederick, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 13, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3633 | 21 CFR 211.170(b)(1) | Reserve sample retention time |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |