There were a handful of warning letters issued to drug manufacturers. FDA continues an unrelenting focus on OTC and contract manufacturers.
We cover warning letters outside the U.S., enforcement of OTC and contract manufacturers/laboratories, import alerts associated with warning letters and data integrity deficiencies.
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.