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.
It also did not submit a report to the FDA after first registering as an outsourcing facility in January 2017, and did not submit reports in June and December 2017 listing the drug products it compounded in the previous 6 months.
Investigators additionally noted products intended to be sterile were subject to insanitary conditions that risked their contamination and rendered them adulterated. For example, the company continued to produce commercial products before it successfully completed its media fill validation protocol.
The firm also did not perform media fill validation for its automated vial filling machine, which was used to fill sterile drug products.
The company marketed drug products that had no FDA-approved applications on file and its labeling of certain products failed to give adequate directions for their intended use.
The agency also found multiple deficient corrective actions, and the investigators were unable to fully evaluate some corrective actions because they lacked supporting documentation.