Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistExela Pharma Sciences LLC, registered as an outsourcing facility for compounding sterile drugs, produced drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection from June to July 2019, investigators identified violations related to unapproved new drugs, compounding practices, and misbranding that rendered the company's products noncompliant with federal law. The company had registered as an outsourcing facility in June 2014 and most recently in November 2020, but failed to maintain the necessary compliance standards for this registration status.