Drug factory · FDA FEI 6898

Baxter, S.A. de C.V.

Av. de Los 50 Metros No. 2, Jiutepec, Mexico

Mexico: 1

No problems found at FDA's last inspection, Dec 14, 2018.

No Action Indicated: inspectors found no objectionable conditions.

2 drug inspections on record since 2014: 2 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Calcium Chloride, Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium ChMakes it, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 24571-103, 24571-105
Calcium Chloride, Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, PotasMakes it, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 24571-116
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium ChloridMakes it, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 0941-0679
Lactic Acid and Magnesium Cation and Sodium CationMakes it, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 24571-113
Magnesium Chloride, Dextrose Anhydrous, Lactic Acid, Sodium Chloride, Sodium BicMakes it, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 24571-102, 24571-111, 24571-114
Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Sodium Phosphate, and PoMakes it, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 24571-117
Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and DextroMakes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it Vantive US Healthcare LLC 0941-0409, 0941-0411, 0941-0413 +4

FDA inspection history

EndedResultProgramProblems noted
Dec 14, 2018No problems foundDrug Quality Assurance—
Oct 24, 2014No problems foundDrug Quality Assurance—

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