FDA Inspection 856596 — Baxter Corporation Englewood Daytona Beach
The FDA completed an inspection of Baxter Corporation Englewood Daytona Beach on Nov 6, 2013 in Daytona Beach, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 6, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Daytona Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |