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Purpose and Regulatory Framework 1.1 Objective of the Report The primary objective of this report is to conduct an exhaustive, evaluation of Warning Letters issued by the United States Food and Drug Administration (FDA) during the calendar year 2025 to Pharmaceutical and Active Pharmaceutical Ingredient (API) manufacturing companies

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The difference lies in manufacturing location: brand-name Ozempic is manufactured in FDA-approved facilities, while compounded versions are prepared in licensed 503A pharmacies