FDA Inspection 1069934 — Cardinal Health 414, LLC
The FDA completed an inspection of Cardinal Health 414, LLC on Oct 26, 2018 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
- Oct 26, 2018
- Fiscal Year
- 2019
- 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 |
| 17877 | 21 CFR 212.70(c) | Conform to specs prior to release |
| 17898 | 21 CFR 212.71(c) | Correction of problems |
| 17941 | 21 CFR 212.71(b) | Documentation of Non-Conforming Product Investigation |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |