Drug factory · FDA FEI 3006188375

Laboratorios Leon Farma SAU

CALLE LA VALLINA (POL. INDUSTRIAL NAVATEJERA), S/N, Villaquilambre, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2025.

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

8 drug inspections on record since 2009: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DrospirenoneMakes it and tests it Everett Laboratories, Inc. 0642-7470
Drospirenone and Ethinyl EstradiolMakes it, tests it, packages it and labels it Xiromed, LLC. 70700-114, 70700-115
EstradiolMakes it, tests it, packages it and labels it Xiromed, LLC. 70700-143, 70700-144, 70700-145 +2
Ethinyl Estradiol and EtonogestrelMakes it, tests it, packages it and labels it Northstar Rx LLC., Xiromed, LLC. 16714-029, 70700-156
Ethinyl Estradiol and LevonorgestrelMakes it, tests it, packages it and labels it Everett Laboratories, Inc., Xiromed, LLC. 0642-7471, 70700-123, 70700-124 +1
Ethinyl Estradiol and NorethindroneMakes it, tests it, packages it and labels it Xiromed, LLC. 70700-101
Ethinyl Estradiol and NorgestimateMakes it, tests it, packages it and labels it Xiromed, LLC. 70700-121
ProgesteroneMakes it, tests it, packages it and labels it Northstar Rx LLC., Xiromed, LLC. 16714-157, 16714-158, 70700-162 +2
TestosteroneMakes it, tests it, packages it and labels it Northstar Rx LLC., Xiromed, LLC. 72603-265, 70700-112

FDA inspection history

EndedResultProgramProblems noted
Jul 11, 2025Problems found, fixed voluntarilyBioresearch Monitoring—
Jan 17, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 31, 2023No problems foundDrug Quality Assurance—
Feb 25, 2021No problems foundDrug Quality Assurance—
Mar 8, 2018No problems foundDrug Quality Assurance—
Mar 28, 2014No problems foundDrug Quality Assurance—
Feb 9, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 26, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

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