GMP certificates for USA manufacturers

Is it possible to submit an excerpt from the FDA inspection database as documentation of GMP status?

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.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director

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