After fifteen years of zero FDA enforcement activity, Immunomedics was hit hard not once, but twice in one month. The second punch was concerning enough to thrust them into the spotlight, causing their stock to be sold and their shares to plummet.
FDA issues the first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act.
This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.
FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.
We compiled last week’s warning letters for you. Take a look.