FDA EIR - Corden Pharma Colorado, Inc. - February 12, 2016

An FDA surveillance inspection of Corden Pharma Colorado, Inc. in Boulder, CO, was conducted from February 8-12, 2016. This abbreviated cGMP inspection focused on the manufacturing of Active Pharmaceutical Ingredients (APIs), including Valganciclovir, Ganciclovir, and Enfuvirtide, evaluating the company's Quality, Laboratory, and Material Systems under Compliance Program 7356.002F. Notably, the inspection concluded with no cGMP deficiencies identified, and no Form FDA 483, Inspectional Observations, was issued. This indicates significant improvement since the previous inspection in June 2013, which had resulted in a Form FDA 483 for issues such as inadequate investigation of discrepancies, disrepair in the raw material sampling room, and failure to follow procedures. All these prior observations were confirmed as corrected during the current visit. However, management discussed one key observation: the Quality Control water sampling and analysis for the purified water systems were deemed not fully representative of water used for production. While an annual requalification of all points occurs, routine sampling frequency at other points was considered insufficient. The firm's management committed to reassess and improve their water sampling methods. Additionally, the inspection discussed a Field Alert Report concerning the past misidentification of impurities in Enfuvirtide API due to an analytical method limitation; the firm and its partner are addressing this by updating specifications and methods to ensure accurate impurity identification.