FDA 483 - Buchler Gmbh - August 12, 2019

An FDA inspection of Buchler Gmbh, an API manufacturer in D-3810 Bruanschweig, DE, revealed significant deficiencies in their quality systems. Observations included inadequate validation of computer systems for data protection and backup, insufficient cleaning validation protocols, and a lack of stability data for all product containers sold to the market. These issues indicate a need for improved data integrity, validation practices, and quality control.