483
Emery PharmaEmery Pharma – FDA 483, Apr 9, 2021
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.
View Company Profile
ID · 24d0701e-3f10-4dd3-a311-e1c2e12773bc
Other documents for Emery Pharma
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.