A Double Dose of Reality: A Look Back at What Went Wrong at KV Pharma

The saga of KV Pharmaceutical provides a cautionary tale for any manufacturer who would overlook manufacturing quality issues and attempt to fly under the regulatory radar. As most in the industry know, KV has gone from a model growth company to one on the brink of bankruptcy, following manufacturing issues which included the production of oversized tablets (some of which contained double doses of API), and then subsequent attempts to falsify records and cover up the problems.