Pharmaceutical Good Manufacturing Practice Regulations Article 52

Chinese herbal medicine factories shall establish in writing procedures for the handling of oral and written complaints from consumers; all oral and written complaints shall be investigated and assessed by the quality control departments of aforesaid factories.Where Chinese herbal medicine factories discover serious and unanticipated product defects, they shall report aforesaid defects to the relevant competent authorities, and handle aforesaid defects in accordance with the stipulations of the Act.Written records shall be kept of the handling of all complaints; aforesaid records shall be properly collated and filed.