FDA 483 - McKinley Resources Inc. - July 30, 2015

An FDA inspection of McKinley Resources, an API supplier for OTC products in Dallas, TX, revealed issues with their Certificate of Analysis (CoA) practices. The firm was observed creating new CoAs on their letterhead for received products without including essential information from the original manufacturer or laboratory, and without attaching the original manufacturer's CoA upon shipment. This indicates a concern with the integrity and traceability of product documentation.