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Teetering Akorn hit with another FDA warning letter fiercepharma
June 28, 2019
For Akorn, when it rains, it monsoons. The sterile and generics maker, whose $4.3 billion buyout by Fresenius was swept away because of manufacturing failures, has received its second warning letter this year, even as it is in the process of renegotiating
Pfizer still unable to get on top of problems at Hospira injectables plant fiercepharma
December 14, 2018
Since Pfizer’s Kansas plant received an FDA warning letter last year, the company has insisted it is making good progress on turning things around at the essential but troubled injectables facility.
China's Zhejiang Huahai lambasted in FDA warning letter for putting profits ahead of safety fiercepharma
December 12, 2018
Instead, the FDA says Huahai accepted the returned batches, then “reprocessed and released [them] to customers in non-U.S. markets.”
Sun wins approval of glaucoma drug and its once-troubled Halol plant to produce it fiercepharma
September 30, 2018
Sun Pharmaceutical will produce a new eye drug at the plant in Halol after resolving FDA concerns there.
Ascend scolded—again—for estrogen drug promos in OPDP's 4th warning this year fiercepharma
August 30, 2018
The FDA's policing arm, OPDP, sent another warning letter to Ascend Therapeutics over misleading marketing materials for estrogen therapy EstroGel.