India’s Megafine Pharma has received its second FDA warning letter in 10 months, this one for an API intermediates plant in India.

Wockhardt has received an untitled letter for a sterile injectables plant in India that Wockhardt is trying to get approved by the FDA to sell into the U.S.

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…

Novartis is still facing fallout from last year’s kickbacks case in South Korea. Officials there levied a set of punishments and are weighing "tougher…

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

Dr. Reddy’s had hoped to start moving beyond an FDA warning letter that lambasted three of its India plants for data integrity and other issues in 2015, but…

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.

Regulatory