FDA Inspection 1098380 - Intas Pharmaceuticals Limited - August 02, 2019

FDA Inspection 1098380 for Intas Pharmaceuticals Limited on August 02, 2019. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1098380 for Intas Pharmaceuticals Limited on August 02, 2019. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 211.100(a)

21 CFR 211.100(b)

21 CFR 211.113(b)

21 CFR 211.160(b)

21 CFR 211.160(b)(4)

21 CFR 211.194(a)(2)

21 CFR 211.22(d)

21 CFR 211.42(c)(10)(iii)

21 CFR 211.42(c)(10)(iv)

21 CFR 211.46(b)

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Record Information

Company

Intas Pharmaceuticals Limited

Inspection Date

August 2, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: 0895eb6a-065a-49a6-ac84-da712eda4358

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