FDA 483 - AVASOL LLC - November 09, 2023

AVASOL LLC in Santa Barbara, CA, was inspected and received a Form 483 with seven observations related to significant deficiencies in their manufacturing processes for OTC drug products. The inspection revealed issues across stability studies, process validation, master and batch production records, component identity testing, equipment qualification, and cleaning procedures. These findings indicate a lack of adequate controls to ensure product quality and compliance.