FDA 483 - Dermolab Pharma Ltd. - October 13, 2023

Dermolab Pharma Ltd. in Sainte-Julie was inspected and cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products. Observations included a lack of validated manufacturing processes, inadequate investigation of microbial excursions, insufficient raw material testing, and the absence of annual product reviews. These issues indicate a severe lack of control over product quality and compliance.