FDA Inspection 1271145 — Bioggio Pharma Manufacture SA
The FDA completed an inspection of Bioggio Pharma Manufacture SA on May 23, 2025 in Bioggio. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Bioggio (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |