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Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection

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Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/25/2025
Short Title (70 char) IntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 07/25/2025
FEI Number 3014483112
Firm Name IntegraDose Compounding Services LLC
Record Type 483
State MN
Establi

FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bu