We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies.
Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.
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.
The global supply chain for drug products has become increasingly more complicated, and as such has expanded the scope of sites FDA must routinely inspect.
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.