POET Biorefining - Leipsic, LLC – FDA 483, Jan 17, 2024

An FDA inspection of POET Biorefining - Leipsic, LLC revealed significant deficiencies in the firm's quality unit oversight and manufacturing controls for Purified Alcohol (PA) or API Ethanol. The company failed to establish adequate written procedures for quality control, process validation, stability testing, and microbiological specifications. These observations indicate a lack of robust systems to ensure the quality and purity of their active pharmaceutical ingredients.