Category Archives: The GMP Letter

China’s Food and Drug Administration asked for additional feedback on draft guidance covering its unique device identification system.
Source: The GMP Letter

The FDA flagged three U.S. facilities and two in Europe for a variety of deficiencies including CAPA failures and investigations of nonconforming products.
Source: The GMP Letter

Nearly 80 percent of the 1.6 million medical devices registered in the FDA’s Global Unique Identification Database are Class II medical devices and nearly half are implantable devices, the FDA reported.
Source: The GMP Letter

Massachusetts-based medical device manufacturer Alere and its subsidiary Alere San Diego agreed to pay the United States more than $33 million to resolve False Claims Act allegations that Alere knowingly sold unreliable point-of-care diagnostic testing devices to hospitals.
Source: The GMP Letter

The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts.
Source: The GMP Letter

The FDA issued warning letters to five devicemakers, citing misbranding and significant quality deficiencies.
Source: The GMP Letter

Health Canada announced that sterilant solutions and disinfectants to be used with medical devices are now classified as medical devices.
Source: The GMP Letter

The FDA is moving closer to a decision on whether to add clauses from ISO 13485:2016 to the regulatory requirements for U.S. medical devices.
Source: The GMP Letter

The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan facility revealed adulterated products.
Source: The GMP Letter

The FDA cited ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California.
Source: The GMP Letter