1280962
United-Guardian, Inc. — FEI 2410853
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |