Drug factory · FDA FEI 3000219354

IDT Australia Limited

39-57 Wadhurst Drive, Boronia, Australia

Australia: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 28, 2025.

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

6 drug inspections on record since 2009: 0 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
MinocyclineMakes the active ingredient and tests it Melinta Therapeutics, LLC 70842-160

FDA inspection history

EndedResultProgramProblems noted
Mar 28, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
May 31, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 8, 2017Serious problems, FDA actionDrug Quality Assurance—
Jan 19, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 21, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
May 21, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.