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Regis Technologies Completes FDA Audit

Manufacturing facility found to be in compliance with GMPs for chemicals and APIs.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Regis Technologies successfully completed a recent U.S. FDA audit with no objectionable findings and no Form 483 observations. This is the third inspection in a row for Regis demonstrating compliance.   The 12-day inspection focused on Regis’ Quality and Production systems to support its FDA registration and ongoing manufacture of clinical and commercial active pharmaceutical ingredients (APIs).   FDA investigators use Form 483 to record observations of non-compliance with the agency’s curre...

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