FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Outsourcing Facility Shuttered Under Consent Decree

June 12, 2018

A U.S. District Judge on Friday accepted a consent decree of permanent injunction against a Mississippi drug outsourcing facility, citing repeated failures to correct deficiencies.

Delta Pharma has agreed to halt operations until the FDA is satisfied that its factories are clean and safe. According to the FDA complaint filed with the consent decree, Delta, an outsourcing facility, made injectable corticosteroids and antihistamines tainted by unclean conditions. The complaint also alleged Delta manufactured unapproved and misbranded drugs with inadequate labeling.

The FDA must approve all corrective actions before the facility resumes operations.

FDA Commissioner Scott Gottlieb said the agency is committed to holding outsourcing facilities accountable, but it is also “pursuing new policy steps to help make it more feasible for compounders to meet the requirements of becoming an outsourcing facility. We’re committed to ensuring that we balance the need to preserve access to appropriately compounded drugs with our commitment to help protect patients from drugs compounded under substandard conditions.”

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