Regis Technologies Passes FDA AuditBy
Regis Technologies, a Morton Grove, Illinois-based contract manufacturing organization, has passed a recent US Food and Drug Administration (FDA) inspection at its active pharmaceutical ingredient (API) facility as it earned no objectional findings from the agency. The inspection was a routine quality systems inspection to support Regis' FDA registration and ongoing manufacture of clinical and commercial APIs.The 12-day inspection focused on Regis' quality and production systems.
Regis' 36,000-square foot facility provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies.
Source: Regis Technologies