FDA Inspection 1191833 — Biokosmes Srl
The FDA completed an inspection of Biokosmes Srl on December 2, 2022 in Bosisio Parini. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bosisio Parini (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |