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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
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. 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 has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. 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
Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. 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
Pfizer said Li uploaded over 12,000 documents to her personal drive and devices shortly before she was set to begin working at Xencor, a Monrovia, Calif.-based biotech. Read More