FDA Inspection 905219 — BioGaia Production AB
The FDA completed an inspection of BioGaia Production AB on October 8, 2014 in Eslov. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Eslov (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15969 | 21 CFR 111.117(d) | Quality control operations - equipment functions |