FDA published five GMP drug warning letters and one to a device maker. FDA frequently requests “independent” assessments indicating that they do not think the firms are capable of performing these activities internally.
An FDA drug investigator reports on the ways SOPs and data can introduce unneeded risks in quality management systems.
Enforcement this week included two drug GMP warning letters, both to firms in the US.
We review FY2018 FDA Human Tissue and Cell Therapy Observations and trends since FY2015.
Enforcement includes one untitled letter and one warning letter to cell therapy companies. Also, FDA posted and then removed one warning letter to a device manufacturer.
FDA posted one warning letter to a pharmaceutical firm and 15 to firms that sell CBD products.
We took a snapshot of the seven warning letters FDA sent to food and dietary supplement companies that were posted in October. Violations range from misbranding to the presence of Listeria monocytogenes.
We cover the three FDA warning letters published this week including the second one to Torrent Pharmaceuticals in October 2019.