FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Baxter Called Out for Numerous Issues at Colombian Plant

Dec. 18, 2018

The FDA hit Baxter with a Form 483 after multiple problems were discovered at its Valle del Cauca, Colombia facility during a June 4-8 inspection.

The pharma giant’s Colombian facility, Laboratorios Baxter, shipped finished dosage injectable drugs to the U.S., but failed to test them for sterility prior to their approval and release — a requirement under its certificates of analyses — and didn’t check for visible particulates in all filled drugs.

Reserve samples were not checked for signs of product deterioration and the facility had no criteria for identifying and documenting evidence of product deterioration, such as cloudiness or changes in color. It also did not remove the primary packaging bag of a reserve sample in one instance to ensure there were no signs of leaking.

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