Loading…
Nephron Pharmaceuticals Corporation, an outsourcing facility registered to compound sterile drugs, produced adulterated drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act for exemptions from drug approval requirements. FDA investigators found serious deficiencies in the company's sterile compounding practices during a March-April 2022 inspection that put patients at risk, including a lack of sterility assurance in certain products. The company initiated voluntary recalls of sterile drug products within expiry in May and June 2022 in response to these deficiencies.