Drug factory · FDA FEI 3001229385

Latina Pharma S.P.A

Via Murillo, 7, Sermoneta, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 19, 2024.

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

5 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
BendamustineMakes it, tests it and packages it Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), Slayback Pharma LLC 24338-270, 71225-120
CisplatinMakes it WG Critical Care, LLC. 44567-530
HydroxyureaMakes it Waylis Therapeutics LLC 80725-810, 80725-820, 80725-830 +1
MitotaneMakes it, tests it, packages it and labels it Esteve Pharmaceuticals, S.a., HRA Pharma Rare Diseases 68118-080, 76336-080

FDA inspection history

EndedResultProgramProblems noted
Jan 19, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 27, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 21, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 29, 2015Serious problems, FDA actionDrug Quality Assurance—
Jul 24, 2013Problems found, fixed voluntarilyDrug Quality Assurance—

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