Regis Technologies Reports Successful FDA Audit

January 31, 2014
Pharmaceutical Technology Editors

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-02-05-2014, Volume 10, Issue 2

Regis Technologies passes a recent FDA audit with no Form 483 observations.

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