FDA Inspection 685736 — CareFusion 303, Inc.
The FDA completed an inspection of CareFusion 303, Inc. on Oct 8, 2010 in San Diego, CA. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 8, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |