FDA WARNING_LETTER - Curexa - East, LLC dba Curexa - September 09, 2022

FDA WARNING_LETTER for Curexa - East, LLC dba Curexa on September 09, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Curexa - East, LLC dba Curexa on September 09, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 503A

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 331(k)

21 U.S.C. 352(f)(1)

21 U.S.C. 351(a)(2)(B)

FD&C Act 505

FD&C Act 501(a)(2)(A)

21 U.S.C. 353a

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Record Information

Company

Curexa - East, LLC dba Curexa

Inspection Date

September 9, 2022

Product Type

Drugs

Office

Office of Pharmaceutical Quality

People

Lisa M. Harlan (Program Division Director)

ID: 6aabcedc-38a8-4124-8d2e-e9271b79002d

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