Inspections and Audits

FDA Warns Fusion IV Over Labeling, Compounding Issues

The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section 503B exemptions from the agency’s drug approval requirements. Read More

FDA Warns Fusion IV Over Labeling, Compounding Issues

The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section 503B exemptions from the agency’s drug approval requirements. Read More