FDA WARNING_LETTER - Re-Gen Active Lab, Inc. - July 28, 2021

FDA WARNING_LETTER for Re-Gen Active Lab, Inc. on July 28, 2021. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Re-Gen Active Lab, Inc. on July 28, 2021. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

21 U.S.C. 262(a)(3)

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

21 CFR 211.68(a)

21 CFR 1271

21 CFR 211.166(a)

21 CFR 1271.10(a)(2)

21 U.S.C. 355(i)

42 U.S.C. 262(i)

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Record Information

Company

Re-Gen Active Lab, Inc.

Inspection Date

July 28, 2021

Product Type

Biologics

Office

Office of Biological Products Operations - Division I

People

ID: d42b459c-8a15-4e7e-8f69-94d52e194020

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