1175570
Ultra Chem Labs Corp — FEI 3011622931
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Diamond Bar, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1874 | 21 CFR 211.180(b) | Record maintenance 3 years (exempt OTC drugs) |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |