1048973
Optum Compounding Services, LLC — FEI 3012890460
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |