We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Spartan Chemical didn’t conduct validation studies for the water system used to manufacture drug products, among other quality lapses observed during a recent FDA inspection of the company’s Maumee, Ohio facility. Read More
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to pull the company into full compliance. Read More
The Guyer Institute of Molecular Medicine, an Indianapolis, Ind.-based drug compounder, has drawn a warning letter from the FDA for its sterile drug production. Read More
The FDA issued an update on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to new approaches introduced during the pandemic. Read More
The pandemic forced the FDA to be far more innovative in its efforts to inspect drug manufacturing facilities, and the agency plans to incorporate these new modalities into its site surveillance process going forward. Read More
Of all new product applications the FDA has received since March 2020, decisions on 60 are “currently delayed solely due to the inability to conduct inspections or facility assessments” as of Sept. 30, the agency said. Read More
Dirt floating in so-called sterile vials and other serious quality lapses led the FDA to hit sterile drug manufacturer Toyobo of Otsu, Japan, with an 11-observation Form 483. Read More
The FDA issued an update yesterday on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to new approaches introduced during the pandemic. Read More
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to pull the company into full compliance. Read More
The Guyer Institute of Molecular Medicine, an Indianapolis, Ind.-based drug compounder, has drawn a warning letter from the FDA for its sterile drug production. Read More
The pandemic forced the FDA to be far more innovative in its efforts to inspect drug and device manufacturing facilities, and the agency plans to incorporate these new modalities into its site surveillance process going forward. Read More