Avoiding and Reacting to Human Tissue, Cell and Gene Therapy Enforcement Actions: Communication is Key
“The beauty of the TRIP program,” Laney said, “is that it is informal and non-binding. It is an open forum for tissue manufacturers and processors to talk to the agency and get advice in a way that fuels open communication on a rapid-response timeline.”
The first quarter of 2020 is behind us, and with it, a fresh batch of warning letters sent by the FDA to food and dietary supplement companies.
We’ve compiled a snapshot of all of the letters that posted from January through the end of March and organized them by category provided by the FDA for your convenience. In total, 22 warning letters were sent for various infractions, ranging from FSVP violations to Insanitary Conditions.
We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area.