Enforcement was light on warning letters this week: one to a device manufacturer, one to a compounding pharmacy and one to a homeopathic drug manufacturer.
This week FDA posted 11 warning letters to dietary supplement manufacturers, two to pharma firms and one to a compounding pharmacy. We cover these last three.
Enforcement was busy this week. There were six warning letters sent to drug product manufacturers and one to an in vitro diagnostics firm.
We cover four warning letters from last week, including two to pharmaceutical firms and two to compounding facilities.
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.