FDA Inspection 1048973 — Optum Compounding Services, LLC
The FDA completed an inspection of Optum Compounding Services, LLC on Apr 20, 2018 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 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 |