FDA Inspection
Kelix bio (Malta) Ltd.Kelix bio (Malta) Ltd. – FDA Inspection, Dec 16, 2022
Record Details
This FDA Inspection record concerns Kelix bio (Malta) Ltd., with an inspection on December 16, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kelix bio (Malta) Ltd.
- Inspection Date
- December 16, 2022
- Product Type
- Drugs
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ID · 4f1c29ce-6b07-4fdb-8263-4efb10882a95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192875
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Kelix bio (Malta) Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| February 20, 2018 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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