FDA Inspection 1038753 — Cardinal Health 414, Inc.
The FDA completed an inspection of Cardinal Health 414, Inc. on January 25, 2018 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 25, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17723 | 21 CFR 212.10 | Personnel not qualified |
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17851 | 21 CFR 212.60(c) | Analytical methods |