Regis Technologies, which provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies, reported that it passed a recent FDA audit with no Form 483 observations. Regis’ GMP manufacturing facility, QC laboratory and quality systems were part of the detailed compliance inspection. The company reports that it was the second consecutive audit without a Form 483 observation. Regis operates a 36,000-sq ft facility that includes laboratories and production capabilities with eight dedicated reactor suites, individual kilo lab suites, a cryogenic reactor, and a quality control department. The company has regulatory approvals in 20 countries across the globe.
Source: Regis Technologies