FDA WARNING_LETTER - Valley Biosystems - October 08, 2021

FDA WARNING_LETTER for Valley Biosystems on October 08, 2021. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Valley Biosystems on October 08, 2021. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 58.29(b)

21 CFR 58.190(a)

21 CFR 58.29(a)

21 CFR 58.35(b)(3)

21 CFR 58

21 CFR 58.33

21 CFR 58.130(e)

21 U.S.C. 355

21 CFR 58.35(a)

21 U.S.C. 262

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Record Information

Company

Valley Biosystems

Inspection Date

October 8, 2021

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

People

ID: cca41a22-fd50-485f-99f5-42c03afeb2f5

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