FDA 483 - BioChem Sioux City Inc. - March 19, 2026

BioChem Sioux City, Inc. in Sioux City, IA, was cited with two observations during an FDA inspection of its heparin sodium crude manufacturing operations. The firm failed to establish an ongoing stability program for heparin sodium crude to support its assigned expiration date. Additionally, the company has been using a modified heparin sodium assay method for 15-20 years without proper validation.