FDA 483 - Acrotech Biopharma Inc. - January 19, 2023

ACROTECH BIOPHARMA, Inc. in East Windsor, NJ, was inspected regarding its post-marketing surveillance activities. The inspection revealed significant deficiencies in adverse drug experience reporting, including failures to submit serious and unexpected adverse drug experiences within 15 days, adequately investigate reported cases, and provide supporting scientific literature for alert reports. These issues indicate a systemic problem with the firm's pharmacovigilance processes.