The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure on May 15, aligning inspection staff into seven product categories — and creating three new geographic…
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
FDA inspectors found a DT Medtech facility in Towson, Md., lacked adequate design validation procedures. Source: The GMP Letter
Denttio’s Los Angeles, Calif., facility was hit with a warning letter for inadequate complaint evaluations and CAPA procedures. Source: The GMP Letter
The most common error companies make when conducting internal audits is to take a confrontational approach when fixing them, according to one compliance expert. Source: The GMP Letter
Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies,…