FDA 483 - Huber Soda, LLC - December 06, 2024

An FDA inspection of Huber Soda, LLC in Cortland, NY, an API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate process validation for Sodium Bicarbonate, an unsuitable water system, uncontrolled storage conditions for finished products, and a failure to address persistent poor documentation practices in batch records. These issues collectively indicate a lack of control over critical manufacturing processes and data integrity, potentially impacting product quality.