FDA 483 - BioChem Sioux City Inc. - August 06, 2021

Aspen API, Inc. in Sioux City, Iowa, was inspected regarding its crude heparin manufacturing, revealing significant issues with contamination control and product quality. The firm failed to adequately protect Crude Heparin Sodium from contamination and allowed untrained employees to overrule critical product release decisions. Additionally, the inspection found deficiencies in testing procedures and the accuracy of Certificates of Analysis.