1211138
OMEZA LLC — FEI 3019843904
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 28, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |