FDA 483 - Accra-Pac, Inc. - September 02, 2022

Accra-Pac, Inc. dba Voyant Beauty, LLC in Elkhart, IN, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into product contamination and manufacturing failures, insufficient laboratory controls and data integrity, and a quality unit that does not fully follow its responsibilities and procedures. These issues indicate a systemic breakdown in quality management and control processes.