FDA Inspection 1219743 - Afton Scientific, LLC - October 06, 2023

FDA Inspection 1219743 for Afton Scientific, LLC on October 06, 2023. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1219743 for Afton Scientific, LLC on October 06, 2023. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 117.135(c)(3)

21 CFR 117.410(c)

21 CFR 211.100(a)

21 CFR 211.110(a)

21 CFR 211.142(b)

21 CFR 211.160(b)(3)

21 CFR 211.22(d)

21 CFR 211.25(a)

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Record Information

Company

Afton Scientific, LLC

Inspection Date

October 6, 2023

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: 579233d2-9055-403f-9daf-bc2ac2007b07

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