Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) announced its Nantou manufacturing facility has completed the 5-day inspection by US FDA and received the Establishment Inspection Report today with “zero observations”, or “no action indicated”. This is the fifth inspection by the USFDA since 2010. The FDA investigator reviewed the manufacturing of general drug products and cytotoxic products, warehouse, laboratories, quality systems, utility systems and serialization and found these to be satisfactory.
Lotus Chairman Robert Wessman said,