FDA Inspection
Kelix bio (Malta) Ltd.Kelix bio (Malta) Ltd. – FDA Inspection, May 3, 2019
Record Details
This FDA Inspection record concerns Kelix bio (Malta) Ltd., with an inspection on May 3, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · f8a23e64-4bb7-49fc-844b-709712d90479
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089383
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Kelix bio (Malta) Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2018 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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