Significant API Deviations at Curia New York

A 1/28-2/5 FDA inspection at the Curia New York drug manufacturing facility in Rensselaer, NY, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 9/18 Warning Letter says the specific deviations were:

• failure to have laboratory control records that include complete data from all laboratory tests conducted to ensure API and intermediates comply with established specifications and standards;
• failure of the firm’s quality unit to exercise its responsibility to ensure that API and intermediates manufactured at the facility comply with CGMP; and
• failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes in data.

The letter says Curia’s responses to the inspection observations were inadequate. It directs the company to promptly address the deviations and to ensure that appropriate resources are allocated to fully address the deviations and prevent their recurrence.