FDA 483 - Blaine Labs Inc - December 15, 2023

Blaine Labs Inc, a manufacturer in Santa Fe Springs, CA, was inspected and received a Form 483 with four repeat observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of critical procedures, incomplete validations, and unqualified equipment. Additionally, the firm failed to validate manufacturing processes and store drug products under appropriate temperature conditions.