FDA 483 - Purac America, Inc. - August 02, 2024

The FDA inspection of Purac America Inc. in Tucker, GA, revealed significant deficiencies across its quality control unit, laboratory controls, equipment maintenance, cleanroom operations, and personnel gowning procedures. The firm failed to develop a quality management system for excipients, maintain adequate electronic record controls, and ensure proper cleaning and environmental conditions. These issues indicate a lack of robust systems to prevent contamination and ensure product quality.