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. |
File | US product GMP Information R1.pdf |
Keyword | GMP Certificates |