Drug factory · FDA FEI 3004132818

Antibioticos do Brasil Ltda

Rod SP-332 KM 135 Itapavussu, Cosmópolis, Brazil

Brazil: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2024.

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

7 drug inspections on record since 2008: 1 with no problems, 3 with problems fixed voluntarily, 3 with FDA action.

What it does, for whom

DrugRoleForNDC
CefepimeMakes it and makes the active ingredient Fresenius Kabi, LLC 63323-326, 63323-340

FDA inspection history

EndedResultProgramProblems noted
Dec 13, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
May 27, 2022No problems foundDrug Quality Assurance—
Aug 28, 2018Serious problems, FDA actionDrug Quality Assurance—
Apr 27, 2016Serious problems, FDA actionDrug Quality Assurance—
Feb 26, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 18, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 6, 2008Serious problems, FDA actionDrug Quality Assurance—

Registered with FDA for: api manufacture; manufacture.