FDA 483 - Blaine Labs Inc - September 30, 2019

Blaine Labs Inc. in Santa Fe Springs, CA, was inspected and received 13 observations, many of which were repeat findings, indicating significant deficiencies across its quality system, facility, equipment, production, and laboratory controls. The firm failed to thoroughly investigate discrepancies, lacked critical GMP procedures, and released drug products without proper testing or validated processes, raising serious concerns about product quality and safety.