FDA Inspection 610220 — Cardinal Health
The FDA completed an inspection of Cardinal Health on September 8, 2009 in Deland, FL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Deland, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |