FDA Inspection 920011 — Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda
The FDA completed an inspection of Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda on March 11, 2015 in Bebedouro. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 11, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bebedouro (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 15423 | 21 CFR 111.15(j) | Trash disposal |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15452 | 21 CFR 111.15(f)(5) | Plumbing - backflow, cross connection |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15901 | 21 CFR 111.83(b)(3) | Reserve sample - retained |