Drug factory · FDA FEI 3009883315

Combino Pharm (Malta) Limited

HF60 Hal Far Industrial Estate, Hal Far, Birzebbuga, Malta

Malta: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 6, 2025.

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

3 drug inspections on record since 2019: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
PrucaloprideMakes it, tests it and packages it Somerset Therapeutics, LLC 70069-821, 70069-822

FDA inspection history

EndedResultProgramProblems noted
Feb 6, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 10, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 17, 2019Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; manufacture; pack.