Regis Technologies Reports Successful FDA Audit - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regis Technologies Reports Successful FDA Audit


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 10, Issue 2

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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here