FDA Audit Guide.pdf

FDA 查厂须知 Prepared by Sam Wong Corporate QA/QS 美国FDA QSR 查厂程序 (Content) 了解FDA 查厂政策 了解FDA 查厂程序 了解QSIT 如何准备接受FDA 查厂 Who are subject to QSR Inspection Manufacturer (21 CFR 807.3(d)) “Manufacturer, preparation, propagating, compounding, assembly, or processing” of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of a device in section 201 (h) of the Act. These terms including the following activities: 1/ Repackaging or otherwise changing the container, wrapper, or labeling of any device packaging in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery of sale to the ultimate consumer; 2/ Distribution of domestic or imported devices; or 3/ Initiating of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications. Who are subject to QSR Inspection Re-manufacturer (21 CFR 820.3(w)) Is any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that changes the finished device’s performance or safety specifications or intended use. Re-manufacturers are considered manufacturers. Custom device manufacturers (FDC Act Section 520(b)) Customer device is exempt from 510(k) and PMA, not exempt from GMP requirements. Contract Manufacturers A person that manufactures a finished device under the terms of a contract with another manufacturer. Contract manufacturer shall comply with applicable requirements of GMP and shall register their establishment with FDA. Who are subject to QSR Inspection Re-packagers, Re-labelers and Specifi