A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Source: The GMP Letter

An FDA inspection of Digital Heat’s Tempe, Arizona facility conducted in December 2017 resulted in a nine-item Form 483 for failing to establish design procedures for the firm’s heated eye…

China’s Food and Drug Administration plans to revise more than 300 standards by 2020, according to a new two-year plan for bringing the country’s medical devices and in vitro diagnostics…

Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Source: The GMP…

India’s Drugs Controller General released its final audit fees for notified bodies under its new medical device regulations. Source: The GMP Letter

Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but is making…

The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Source: The GMP Letter

Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Source: The GMP…

Biomodeling Solutions drew an FDA warning letter after it failed to provide written responses to nonconformities identified in a Form 483. Source: The GMP Letter

The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead…