FDA EIR - Valisure, LLC - July 06, 2021

FDA EIR for Valisure, LLC on July 06, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Valisure, LLC on July 06, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211

FD&C Act 582(d)(B)

FD&C Act 582(c)(B)

FD&C Act 582(d)(A)

FD&C Act 582(c)(4)(B)(ii)

FD&C Act 582(d)(4)(B)(ii)

FD&C Act 582(c)(A)

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Record Information

Company

Valisure, LLC

Inspection Date

July 6, 2021

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 94c1f5af-40e9-4d43-b7ab-a030b2a0d423

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