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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
The FDA hit Salisbury, Maryland generic drug manufacturer Jubilant Cadista Pharmaceuticals for failing to control the risk of product contamination and for submitting late field alert reports, among other violations. Read More
After inspecting its facility in Chatsworth, Calif., the FDA rapped Thibiant International for inadequate good manufacturing practices, complaint handling and training. Read More
The FDA issued a warning letter to LEC Custom Products, an over-the-counter drugmaker in Ontario, Canada for serious violations of current good manufacturing practices. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP), which has only issued a handful of warning letters so far this year, sent out two on the same day to drugmakers in South Carolina and New Jersey. Read More
Five drugmakers drew warnings from the FDA for serious quality failures, including “superpotent” products, inadequate stability data and a lack of validation testing. Read More
The FDA cited B. Braun Medical for failing to complete timely corrective and protective actions (CAPAs) following an inspection of its Irvine, Calif. facility. Read More
The FDA issued a warning letter to a drugmaker in India for lacking an adequate environmental monitoring system in its aseptic processing facility. Read More