FDA 483 - Mobren Transport, Inc. - November 16, 2021

Mobren Transport Inc., an API manufacturer in Sioux City, IA, was cited with two observations during an FDA inspection. The firm failed to establish and meet appropriate specifications for crude heparin nano-concentrate, specifically lacking testing for impurities like over-sulfated chondroitin sulfate and non-porcine ruminant material. Additionally, their investigation into a customer complaint of foreign material in crude heparin was deemed inadequate as it did not extend to all potentially affected batches.