“You repeatedly omitted the name and address of the original API manufacturer on the certificates of analysis (COA) you issued to your customers and did not include a copy of the original batch certificate. Additionally, your firm did not conduct a secondary review of ...
(2)GMP证书或者ISO13485等能类似GMP的证书 Certificate of Good Manufacturing Practices of the Manufacturer issued by the National Authority of Pharmaceutical Products, Devices and Sanitary Products or document that accredits the compliance of the Quality Standard specific to the type of medical device Examp...