FDA Inspection 1323986 — Biokosmes Srl
The FDA completed an inspection of Biokosmes Srl on Jun 26, 2026 in Bosisio Parini. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 26, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bosisio Parini (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |