FDA 483 - AVEVA Drug Delivery Systems, Inc. - July 26, 2019

An FDA inspection of AVEVA Drug Delivery Systems, Inc. in Miramar, FL, a manufacturer of transdermal patches and sublingual films, revealed significant issues with quality control. The firm failed to thoroughly review unexplained discrepancies and ensure batches met specifications, as evidenced by undetected manufacturing defects and inadequate investigations. Additionally, the company's appearance specifications for drug products were found to be deficient, lacking clear criteria for handling defective units.