FDA 483 - Wong Lap Kwong Medicine Company Limited - September 22, 2017

Wong Lap Kwong Medicine Company Limited, a manufacturer of human OTC topical solutions in Tseun Wan, Hong Kong SAR, received 24 observations during an FDA inspection from September 18-22, 2017. The observations primarily highlight a systemic lack of written procedures and documentation across quality control, equipment management, material handling, laboratory controls, and production processes. This indicates significant deficiencies in their cGMP compliance and failure to establish basic quality system requirements for drug product manufacturing.