FDA Inspection 828808 — Cardinal Health 414, LLC
The FDA completed an inspection of Cardinal Health 414, LLC on April 25, 2013 in Birmingham, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17757 | 21 CFR 212.20(b) | Examine, approve or reject |
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17813 | 21 CFR 212.50(a) | Written control procedures |
| 17849 | 21 CFR 212.60(a) | Testing procedures |