Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014

摘要

Background: The US Food and Drug Administration (FDA) is responsible for protecting public health. Issuance of a warning letter is the FDA's principal means of achieving prompt voluntary compliance with regulations. The objective of this study is to analyze the trends of warning letters issued to medical products about current good manufacturing practices (CGMP) violations during 2007-2014, with a secondary purpose of providing suggestions to manufacturers on how to avoid warning letters.