FDA 483 - Front Range Laboratories, Incorporated - March 20, 2020

Front Range Laboratories, Incorporated in Loveland, CO, received an FDA Form 483 citing significant deficiencies during an inspection. Observations included inadequate validation of test methods for drug products like Hydromorphone HCl and Fentanyl Citrate, and a lack of established procedures to prevent microbiological contamination for sterile products. Additionally, the firm failed to ensure the accuracy of data inputs and outputs, specifically regarding unvalidated Excel spreadsheets used for critical calculations.