FDA 483 - Acrotech Biopharma Inc. - November 18, 2024

Acrotech Biopharma Inc. in East Windsor, NJ, was cited for significant deficiencies in its postmarketing adverse drug experience reporting during an FDA inspection. The firm failed to report serious and fatal adverse events in a timely manner, did not include supporting scientific literature with alert reports, and lacked essential written procedures for postmarketing surveillance, including monitoring website contact forms and social media. These observations indicate a systemic breakdown in their pharmacovigilance processes.