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The FDA issued warning letters to three drug manufacturing facilities for failures in their current good manufacturing practices, including lax environmental monitoring and inadequate process validations. Read More
Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., has been sent a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Read More
Over the counter (OTC) drugmaker Cosmax USA may have distributed batches of its product contaminated with dangerous bacteria, the FDA said in a warning letter to the Ridgefield Park, N.J. company. Read More
UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Read More
Shilpa Medicare of Karnataka, India, drew a warning letter from the FDA for multiple violations found during an inspection of its sterile drug manufacturing facility. Read More
Generics manufacturer KVK-Tech was slapped with another warning letter from the FDA over violations at a Newtown, Pennsylvania facility, its second of the year. Read More
The FDA cited MasterPharm following an inspection of its South Richmond Hill, N.Y. plant that revealed numerous violations of current good manufacturing practices. Read More
Generic drug titan Aurobindo Pharma announced that its Dayton, N.J., oral drug manufacturing facility has been hit with an FDA warning letter after being previously written up by the agency for a lengthy list of violations. Read More
A Phoenix, Arizona hypothyroid drug manufacturer drew an FDA warning letter after investigators discovered a lack of process validation data and stability studies for two drug products that were found to be sub-potent. Read More
Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Read More
Serious quality control violations discovered in the past year at Eli Lilly’s Branchburg, N.J., facility — a site that is preparing to manufacture the company’s COVID-19 antibody — are being “aggressively” addressed and will not impact product quality or safety, the drugmaker said Wednesday. Read More