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.
The Los Angeles, California facility, which was inspected in March, 2017, compounded drug products that failed to meet all conditions of section 503B exemptions. For example, it compounded products using substances that are ineligible for exemptions under section 503B because they do not appear on the agency’s bulk lists and were not used to compound a drug on the agency’s drug shortage list.
In addition, the company dispensed or distributed certain drug products that did not include the statement “Office Use Only” on the label when necessary. Other products did not include the FDA hotline number and the MedWatch website URL on the container, information required for reporting adverse events.