FDA Inspection 638837 — Baxters North America Inc
The FDA completed an inspection of Baxters North America Inc on January 15, 2010 in Salem, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 15, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Salem, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1424 | 21 CFR 110.20(b)(4) | Drip and condensate |
| 1709 | 21 CFR 110.80(b)(13) | Filling, assembling, packing controls |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |