FDA 483 - Emery Pharma - July 09, 2025

Najafi Pharma, Inc. dba Emery Pharma, a contract testing laboratory in Alameda, CA, received a Form 483 with three observations. The inspection revealed significant deficiencies in computer system controls, including the ability for unauthorized personnel to delete data and the use of unvalidated Excel spreadsheets for critical calculations. Additionally, the firm failed to adhere to written procedures for sampling and testing plans and lacked written quality agreements with clients, indicating a breakdown in their quality control unit's responsibilities.