FDA EIR - Covance Laboratories, Inc. - November 21, 2019

An FDA surveillance inspection was conducted at Covance Laboratories Inc. in Greenfield, IN, from November 20 to November 21, 2019. This inspection focused on the company's contract testing laboratory operations, specifically its Current Good Manufacturing Practice (cGMP) testing for drug products and active pharmaceutical ingredients. The regulatory framework for the inspection adhered to Compliance Programs 7356.002 and 7356.002F, covering drug manufacturing and active pharmaceutical ingredients respectively. Significantly, the inspection concluded without any adverse findings. No Form FDA 483, Inspectional Observations, was issued, and the facility's quality systems and testing operations/controls were found to be compliant with regulatory standards. This classification of "No Action Indicated" reflects a successful inspection. Management concurred with the FDA's recommendation to continuously strive for improvement, even in the absence of identified deficiencies, to prevent any potential gaps in their operations. No specific required actions were mandated as a result of this positive outcome.