FDA EIR - McKinley Resources Inc. - April 04, 2023

An FDA establishment inspection was conducted at McKinley Resources Inc. on April 04, 2023. The inspection focused on the storage and distribution of Vitamin C, a cosmetic ingredient, assessing areas such as distribution practices, sanitation, pest control, employee training, facility conditions, labeling, and complaint handling. The primary observation made during the inspection was the absence of a current food facility registration for the firm. This issue was addressed promptly and corrected by McKinley Resources Inc. on the same day as the inspection. However, it was subsequently clarified by the FDA on April 19, 2023, that registration as a food facility was not actually required for the company's specific operations. As a result of this clarification and the minor nature of the initial observation, no FDA Form 483, which lists significant inspectional observations, was issued to McKinley Resources Inc. The company's president, Mr. John M. Oliver, was reminded of the general obligation to comply with all pertinent regulations. The inspection concluded without any major violations, sample collection, or refusals.