FDA Inspection
Kelix bio (Malta) Ltd.Kelix bio (Malta) Ltd. – FDA Inspection, Feb 20, 2018
Record Details
This FDA Inspection record concerns Kelix bio (Malta) Ltd., with an inspection on February 20, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · b0fe3c1c-fc44-4fbe-bc76-3379a8bee8c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041539
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 117.160(a)Process controls - Validation
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.58Buildings not maintained in good state of repair
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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 |
| May 3, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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