483
McKinley Resources Inc.McKinley Resources Inc. – FDA 483, Jul 30, 2015
Record Details
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.
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ID · 7ac33f0f-c213-426b-b79b-a036ccb8acd9
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