Regis Technologies Reports Successful FDA Audit
PTSM: Pharmaceutical Technology Sourcing and Management
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
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
