Drug factory · FDA FEI 3013541978

Kelix bio (Malta) Ltd.

HHF014 HALFAR INDUSTRIAL ESTATE, HALFAR, Birzebbugia, Malta

Problems found, fixed voluntarily at FDA's last inspection, Dec 16, 2022.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Arsenic Cation (3+)	Makes it, tests it and packages it	Nordic Pharma, Inc.	69918-720
Decitabine	Makes it	Amneal Pharmaceuticals LLC	70121-1644

Ended	Result	Program	Problems noted
Dec 16, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	4

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not documented at the time of performance.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Registered with FDA for: analysis; manufacture; pack.