FDA Inspection 1192875 — Kelix Bio (Malta) Ltd.
The FDA completed an inspection of Kelix Bio (Malta) Ltd. on Dec 16, 2022 in Hal Far, Birzebbuga. 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
- Dec 16, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hal Far, Birzebbuga (Malta)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |