FDA Shuts Down Another 503B Compounder

FDA has shut down another 503B compounder for manufacturing purportedly sterile drugs under insanitary conditions, the agency announced Friday (June 8). The compounder, Delta Pharma, Inc., was issued a Warning Letter in 2014 and 483s in 2016 and 2017. Under the consent decree between the government and Delta Pharma, the compounder is “permanently restrained and enjoined … from directly or indirectly manufacturing, holding, and/or distributing any drugs” until it can demonstrate compliance with the compounding law. The agreement also includes...