FDA EIR - Emery Pharma - April 09, 2021

An FDA Pre-Approval Inspection of Najafi Pharma, Inc. (dba Emery Pharma), a contract testing laboratory in Alameda, CA, was conducted from April 7 to 9, 2021. The inspection, performed under FDA compliance programs for drug process inspection and method verification, aimed to assess the firm's operations. The inspection identified significant issues documented in a one-item FDA Form 483. The primary concern was the inadequacy or non-adherence to written procedures, particularly regarding data integrity within laboratory computerized systems. Specific violations included the absence of unique usernames and passwords for software used in identification testing. Furthermore, raw data and audit trails could be modified or deleted, with the Director of Quality possessing administrative access across all laboratory computer systems, raising concerns about data control. Additionally, Najafi Pharma lacked an approved procedure for the release testing of materials and an established procedure for defining user roles and associated privileges for its computerized systems. The company acknowledged these deficiencies during the inspection's close-out and committed to responding to the FDA with corrective actions within 15 business days.