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Avantor Sciences

GMP certificates for Products Manufactured in the United States

Information

Question Do you have GMP Certificates for Products Manufactured in the United States?
Answer

Please be advised that the United States Food and Drug Administration (USFDA) do not issue GMP certificates. However, they do maintain Establishment Inspection Reports (EIR).

A company's status may be verified via publicly accessible databases: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

A company that meets the definition of an Establishment and is appropriately registered and has listed its products is to be assumed in compliance with the various applicable regulations unless the FDA has taken action to indicate otherwise. Typically, public notification is made via periodic Warning Letters Updates.

Trademarks are owned by Avantor Performance Materials, LLC. or its affiliates unless otherwise noted.
2020 Avantor Performance Materials, LLC.

File US product GMP Information R1.pdf
Keyword GMP Certificates
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