FDA Inspection 1277070 — Cardinal Health 414, LLC
The FDA completed an inspection of Cardinal Health 414, LLC on Jul 31, 2025 in Fort Lauderdale, FL. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17898 | 21 CFR 212.71(c) | Correction of problems |
| 17941 | 21 CFR 212.71(b) | Documentation of Non-Conforming Product Investigation |
| 22744 | FDCA 501(a)(2)(A) | Personnel, blocked or disrupted first air |
| 22761 | FDCA 501(a)(2)(A) | Lack of disinfection, equipment/supplies from lower to higher quality air |