This was a very light week for warning letters with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it here.
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.
We cover two warning letters to compounding pharmacies. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago.
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.