FDA 483 - Asanuma Corporation - June 15, 2018

Asanuma Corporation, an OTC drug manufacturer in Sagamihara-shi, Japan, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate controls over computerized systems, deficient testing and sampling procedures, and a lack of proper written procedures and adherence to change control for manufacturing, packaging, and quality control processes. The firm also failed to adequately qualify equipment and document complaint investigations.