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 cover the three FDA warning letters published this week including the second one to Torrent Pharmaceuticals in October 2019.
Join Govzilla’s GMP Quality Expert Jerry Chapman for an informative 1-hour webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.
A busy week for enforcement. Included in this week of warning letters are Dollar Tree (in which FD&C Act is cited rather than CFR), Cadila Healthcare Limited, and Mylan Laboratories Limited among others.