FDA 483 - TOLMAR, Inc. - February 24, 2020

TOLMAR, Inc. in Windsor, CO, a sterile parenteral and topical drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into discrepancies, a lack of established procedures to prevent microbiological contamination in sterile drug production, and insufficient environmental and equipment controls. These issues indicate a systemic failure in maintaining a state of control over critical manufacturing processes and quality systems.