The FDA and the European Medicines Agency have agreed to recognize the plant inspections each does in their own areas.

India’s Wockhardt has received an FDA warning letter for a plant in the U.S., making an even half-dozen warning letters for seven Wockhardt plants, three of…

Akorn has gotten the all-clear from the FDA for its sterile manufacturing site in Decatur, Illinois, that was cited in a Form 483 last year.

The FDA has sent Pfizer a warning letter for a former Hospira plant in McPherson, Kansas, for repeating some of the mistakes noted in earlier warning letters.

Zhejiang Bangli Medical Products, a medical dressing manufacturer in China, received a warning letter for limiting an FDA inspection.

President Trump told Robert Kennedy Jr. he won't "back down" from plans to create vax safety commission, despite guaranteed "uproar"…

In a warning letter, the FDA shows its dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness.

The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying…

The FDA has again slammed a Japanese drug company in a warning letter, this time for not doing enough to prevent contamination during aseptic filling.

Drug Safety