Placing a company on the FDA import alert list does not guarantee its products won't get into the U.S., as a recent warning letter shows.

The FDA said in a warning letter that an Indian API maker had not ensured that water it gets from a nearby river is sanitary before using it to make its…

Sun Pharma has worked its way out from underneath an FDA ban on a plant it got in its 2015 buyout of Ranbaxy Laboratories.

India’s Wockhardt, which now has a record seven FDA warning letters for its plants on three continents, appears to be reaching a breaking point with the agency.

China’s BeiGene, which is developing a portfolio of immuno-oncology drugs, has struck a deal with a Chinese development agency to build a biologics plant to…

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…

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…

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