FDA Inspection 1175570 — Ultra Chem Labs Corp
The FDA completed an inspection of Ultra Chem Labs Corp on July 27, 2022 in Diamond Bar, CA. 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
- 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 |