FDA Inspection 1144535 - Novartis Gene Therapies, Inc. - June 16, 2021

FDA Inspection 1144535 for Novartis Gene Therapies, Inc. on June 16, 2021. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1144535 for Novartis Gene Therapies, Inc. on June 16, 2021. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 211.113(b)

21 CFR 211.160(a)

21 CFR 211.170(b)(1)

21 CFR 211.194(a)

21 CFR 212.40(b)

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Record Information

Company

Novartis Gene Therapies, Inc.

Inspection Date

June 16, 2021

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: 13259416-d963-4c3e-9e31-3b3d50b8daf5

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