Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.
On April 30, 2019, Regis Technologies reported that no Form 483 observations were issued following a four-day, onsite FDA inspection. The inspection was a routine quality systems inspection to support the company’s FDA registration and ongoing manufacture of clinical and commercial APIs.
The 80,000-ft2 facility near Chicago, IL provides synthesis, analytical, and manufacturing services to pharmaceutical and biotechnology companies. The company works with high-value intermediates and APIs from process development and scale-up through final validation and commercial manufacturing. The company also offers pharmaceutical regulatory support services as well as chromatography products and services.
Source: Regis Technologies
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.