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

During an FDA inspection from March 16-20, 2020, Front Range Laboratories, Incorporated, a testing laboratory located at 3985 S Lincoln Ave, Loveland, CO, received a Form 483 with three observations. Jennifer R. Travis, CFO/COO, was the individual to whom the report was issued.

Observation 1 noted that the accuracy, specificity, and reproducibility of test methods were not established. Specifically, specificity studies for HPLC assay methods for Hydromorphone HCl and Fentanyl Citrate/Injection were inadequate, lacking determination of chromatographic separation of impurities and active peaks, and fortification of known impurities. The procedure HPLC-SOP-008, "Drug Product [(b)(4)] Study," was deficient as it did not specify [(b)(4)] concentrations or exposure times, and did not follow ICH [(b)(4)] Stability guidelines despite referencing ICH and USP. These methods were used for assaying Hydromorphone HCl and Fentanyl Citrate drug products.

Observation 2 stated that procedures to prevent microbiological contamination of sterile drug products were not established and written. Airflow visualization (smoke) studies from October 24, 2014, were deficient as they did not consider the effect of maximum sample load, equipment, or operators within ISO 5 classified laminar flow hoods and ISO classified areas on unidirectional airflow.

Observation 3 identified that input to and output from records or