The FDA cited eight device firms for a range of compliance issues including inadequate complaint procedures, lack of written quality procedures, shipping products prior to approval, inadequate documentation, and unreported…

Brazil’s National Agency for Sanitary Vigilance (ANVS) has introduced a risk-based approach to inspections for devicemakers. Source: The GMP Letter

South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. Source: The GMP…

The FDA issued warning letters to four medical device firms citing serious CAPA and other violations, including inadequate complaint response, quality testing, and verification of shipping and packaging methods to…

The confirmation of Scott Gottlieb as the next FDA commissioner moved one step closer after a Senate panel voted 14-9 in his favor. Source: The GMP Letter