FDA Inspection 1078569 - Ajinomoto Althea, Inc. - February 07, 2019

FDA Inspection 1078569 for Ajinomoto Althea, Inc. on February 07, 2019. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1078569 for Ajinomoto Althea, Inc. on February 07, 2019. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 211.113(b)

21 CFR 211.122(d)

21 CFR 211.125(a)

21 CFR 211.160(b)(3)

21 CFR 211.192

21 CFR 211.42(c)(10)(ii)

21 CFR 211.63

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Record Information

Company

Ajinomoto Althea, Inc.

Inspection Date

February 7, 2019

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: 41c45598-ec98-45ca-9472-600f8ac310e2

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