McKinley Resources Inc. – FDA EIR, Aug 7, 2015

An FDA inspection of McKinley Resources, a third-party logistics company involved in receiving, storing, labeling, and distributing Active Pharmaceutical Ingredients (APIs), took place from July 22 to August 7, 2015. The inspection was conducted to ascertain the firm's adherence to current Good Manufacturing Practices (cGMP) for drug product handling, as required by Section 501(a)(2)(B) of the Act. The main observation, documented in an FDA Form 483, highlighted McKinley Resources' practice of creating new Certificates of Analysis (CoAs). These CoAs were deficient as they did not reference the original API manufacturer, lacked information about the analytical laboratory, and were not accompanied by the original manufacturer's CoA during shipment to customers. Furthermore, the inspection discussions identified additional areas for improvement, including the need for more robust sampling and testing of incoming products and the development of a more detailed Quality Management procedure. In response to these findings, McKinley Resources' management committed to implementing necessary corrections and submitted a written response to the FDA. The inspection specifically reviewed the firm's quality control, facilities and equipment, and labeling systems.