News Summary

• The FDA is cracking down on a generic drugmaker that was the subject of a ProPublica investigation last year.
• A Glenmark Pharmaceuticals factory in central India was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm American patients.
• The FDA has sent Glenmark a warning letter, a disciplinary tool the regulator uses to lay out significant violations of federal requirements and demand changes.
• If Glenmark fails to fix any of the problems outlined, the FDA warned, it may bar drugs made at the factory from entering the U.S.