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You are here: Industry Insights > Form 483

News List

Another day, another Form 483 for a Dr. Reddy's plant fiercepharma
August 04, 2019
FDA inspectors keep hitting replay for Dr. Reddy’s Laboratories plants as they make their way through its manufacturing sites.
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.
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.
FDA berates Chinese drugmaker tied to global valsartan recall fiercepharma
September 30, 2018
The FDA last month went back into China's Zhejiang Huahai Pharmaceutical and produced a Form 483 with observations that strike at the heart of its manufacturing changes.
Valeant says it is getting on top of situation at troubled Bausch + Lomb plant tied to CRLs fiercepharma
August 18, 2017
Valeant Pharmaceuticals says that the FDA has noted improvements at its plant in Florida whose manufacturing issues have kept it from getting an approval for a new eye drug.