FDA 483 - Colorado Histo-Prep - May 10, 2013

An FDA inspection of Colorado Histo-Prep, a GLP Contract Facility in Fort Collins, CO, revealed extensive deficiencies across its operations. The firm failed to adequately manage its quality assurance unit, ensure proper conduct of nonclinical laboratory studies, maintain appropriate personnel training, validate and maintain equipment, and establish comprehensive standard operating procedures. These issues indicate a systemic lack of adherence to Good Laboratory Practice regulations, impacting data integrity and study reliability.