FDA Inspection 1148980 — Optum Compounding Services, LLC
The FDA completed an inspection of Optum Compounding Services, LLC on August 13, 2021 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 13, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |