Oral Biotech, LLC – FDA 483, Oct 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.
ID · 25734b20-f436-4a7e-97b1-8bd2d482901d
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