FDA 483 - Nippon Shikizai, Inc. - September 12, 2025

Nippo Shikizai, Inc., a contract manufacturer of OTC drug products in Tsukuba, Japan, received six observations during an FDA inspection. The findings indicate significant deficiencies in cleaning validation, OOS investigations, component identity testing, equipment log maintenance, process validation, and the stability program. One observation regarding cleaning validation was a repeat from a previous inspection, highlighting persistent issues.