Manufacturers from the USA frequently experience the problem that GMP certificates are not issued by the American Food and Drug Administration (FDA). Similar to the EMA, the FDA keeps a database recording the GMP status of manufacturers (but without the option of downloading a corresponding GMP certificate). This FDA database (https://www.accessdata.fda.gov/scripts/inspsearch) provides information about the results of the inspections, but it does not provide details about the products/facilities checked during these inspections. As the FDA very often conducts product-specific inspections, it is not possible to derive an overall assessment of the site from this entry. As a result, aspects about the inspected products/facilities must be demonstrated by other documents. Therefore, the excerpt from the FDA inspection database is not adequate.
Dr. Katharina Oehler
Scientific and Managing Director
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