FDA 483 - Dougherty's Pharmacy - July 01, 2019

Dougherty's Pharmacy in Dallas, TX, a producer of sterile and non-sterile drugs, was cited for significant deficiencies during an FDA inspection. Observations included inadequate controls to prevent contamination during adjacent construction, poor aseptic technique posing a risk to sterile drug processing, and a failure to conduct media fill studies under worst-case conditions. These issues indicate a lack of control over the manufacturing environment and processes, potentially compromising product quality and sterility.