FDA 483 - Chemblend of America LLC - June 07, 2024

Chemblend of America LLC in Bensenville, IL, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The firm lacked a quality control unit and adequate quality systems for drug products. Key issues included the absence of stability testing, proper identity testing for components, and validated procedures for manufacturing and preventing microbial contamination, particularly for its 70% isopropyl alcohol hand sanitizer.