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doi: 10.1074/jbc.RA119.009094 152 TurpinSMNichollsHTWillmesDMMourierABrodesserSWunderlichCMet al

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Warning Letters issued to 503B Outsourcing Facilities were for cGMP violations, failure to submit Adverse Drug Reaction (ADR) reports to FDA (which 503B facilities are required to report), compounding unapproved drug products