FDA 483 - Austin Biotechnology Inc. - May 29, 2015

Austin Biotechnology Inc. in Taipei, Taiwan, a drug manufacturer, was cited with ten observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including the absence of a quality control unit, inadequate production and stability records, and issues with product labeling and testing. These findings indicate a severe lack of adherence to good manufacturing practices for drug products.