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

Conclusions: The issuance number of warning letters increased during 2009-2011. Medical device manufacturers received the largest numbers of letters. The issuance number and type of warning letters were greatly influenced by changes in FDA’s internal enforcement procedures, drug policies and regulations, as well as other departments’ regulations. Manufacturers should comply with regulations voluntarily and respond promptly to policy changes.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Regulatory Science Source Type: research