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
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.