FDA 483 - Emery Pharma - April 09, 2021

Najafi Pharma, Inc. (d.b.a. Emery Pharma) in Alameda, CA, a control testing laboratory, was inspected from April 7-9, 2021. The inspection revealed significant data integrity issues, including a failure to follow SOPs regarding unique user credentials and the security of raw data and audit trail files. These conditions indicate a moderate severity of non-compliance related to data control and record keeping.