FDA 483 - AMWARE FULFILLMENT SERVICES INC - June 22, 2023

AMWARE FULFILLMENT SERVICES INC, a repacker/relabeler in Dayton, NJ, was cited by the FDA for significant deficiencies in its operations. The inspection revealed that employees involved in repackaging OTC drug products had not received appropriate Good Manufacturing Practices (GMP) training. Furthermore, the firm failed to establish necessary GMP procedures since the commencement of these repackaging activities.