Emery PharmaApril 9, 2021

FDA 483 - Emery Pharma - April 09, 2021

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Record Details

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.

Company: Emery Pharma
Inspection Date: April 9, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
People: Lisa Tran, CSO
Khoa Nathan V. Tran (issuing_officer)
Scott N. Lim

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ID · 24d0701e-3f10-4dd3-a311-e1c2e12773bc