Breaking News

Regis Technologies’ 2019 FDA Inspection Yields NAI Classification

Fourth consecutive inspection with no 483s

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Regis Technologies has reported the successful outcome of its routine U.S. FDA inspection, which found no objectionable findings, meaning no Form 483 observations were issued. This marks the fourth consecutive inspection for Regis without incident.   The inspection was a routine Quality Systems inspection to support Regis’ FDA registration and ongoing manufacture of clinical and commercial active pharmaceutical ingredients (APIs). The four-day, onsite inspection resulted in an NAI (No Action Ind...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters