FDA 483 - Dental Alliance Holdings LLC - October 24, 2024

An FDA inspection of Dental Alliance Holdings LLC in Albany, OR, a drug manufacturer, revealed significant deficiencies in its quality control unit, manufacturing process validation, and equipment qualification. The firm failed to test high-risk components, lacked stability data for expiration dates, and did not conduct annual product reviews or CGMP training. Additionally, the facility exhibited poor design and control, leading to potential cross-contamination and inadequate environmental monitoring.