Cipla clarified that its supply partner Pharmathen received nine USFDA Form 483 observations during a November 2025 ...

Cipla had earlier received final USFDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths.

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...

The FDA hit Eugia, a unit of Indian drugmaker Aurobindo, with a classification of “Official Action Indicated” in the wake of a plant inspection at its Bhiwadi Unit II facility in April and May. The ...

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...