Information and Alerts
Important Information
Pending Government Action
On February 8, 2022, The United States Food and Drug Administration (FDA) sent Yusef Manufacturing Laboratories a warning letter. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals identified during inspection of the facility that took place September 20 to 24, 2021. The letter also states the firm was previously cited for similar CGMP violations and observations in a warning letter issued in 2017.
Due to failure to correct repeat violations the FDA is strongly recommending the firm engage a consultant to assist in meeting CGMP requirements. The FDA requested Yusef Manufacturing Laboratories provide a response within 15 days of receiving their letter with the specific steps the business has taken to address and prevent future violations.
Service Area
- UT
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