Bryant Ranch Prepack, Inc. – FDA 483, Jul 16, 2026

Bryant Ranch PrePack in Burbank, CA, was inspected and received a Form 483 with four observations primarily related to inadequate contamination control and cleaning validation for hazardous and non-hazardous drug products. The firm also failed to thoroughly investigate microbial out-of-specification results and lacked proper systems for Drug Supply Chain Security Act (DSCSA) verification requests. These issues indicate significant deficiencies in quality control and compliance, posing a risk of cross-contamination and product integrity.