No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
We all “know” FDA doesn’t cite Part 11 in 483s, right? Well, maybe.
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.
Clinical service provider or CRO? Observations of FDA enforcement.
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
EDC or CRO? Perceptions of data control.
When is a CRO not a CRO? A look at 21 CFR Part 312.