FDA 483 - Transdermal Delivery Solutions Corp. dba Hypospray Pharma - December 03, 2019

Transdermal Delivery Solutions Corp. dba Hypospray Pharma in Palm Beach Gardens, FL, a drug manufacturer, was cited for multiple significant cGMP deficiencies during an FDA inspection. The observations highlight a pervasive lack of quality oversight, including failures in quality unit responsibilities, investigation of out-of-specification results, equipment control, stability data for expiration dating, and labeling controls. These issues indicate a broad breakdown in the firm's quality system.