OR WAIT null SECS
FDA found no observations during recent inspection of Regis Technologies manufacturing site.
Regis Technologies has announced that no Form 483 observations were issued following a recent 12-day inspection by FDA of the quality and production systems at its Chicago-area facility. The inspection was a routine quality systems inspection to support Regis’ FDA registration and ongoing manufacture of clinical and commercial APIs, according to a Aug. 25, 2016 company statement.
Regis provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies from its 36,000-sq-ft facility.
The company works with high value intermediates and APIs from process development and scale-up through validation and commercial manufacturing. The company also offers pharmaceutical regulatory support services, and access to its proprietary innovative chromatography products and services.
Source: Regis Technologies