FDA Inspection 986617 - Groupe Rocher Operations, SAS - September 09, 2016

FDA Inspection 986617 for Groupe Rocher Operations, SAS on September 09, 2016. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 986617 for Groupe Rocher Operations, SAS on September 09, 2016. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 211.100(b)

21 CFR 211.101(d)

21 CFR 211.111

21 CFR 211.113(a)

21 CFR 211.160(a)

21 CFR 211.160(b)

21 CFR 211.165(e)

21 CFR 211.170(b)

21 CFR 211.192

21 CFR 211.194(a)

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Record Information

Company

Groupe Rocher Operations, SAS

Inspection Date

September 9, 2016

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: fa0c4875-f8bf-4ef6-9f4a-efc2cc97f460

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