FDA Inspection 1075781 - Seaway Pharma Inc. - December 10, 2018

FDA Inspection 1075781 for Seaway Pharma Inc. on December 10, 2018. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1075781 for Seaway Pharma Inc. on December 10, 2018. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 211.130(e)

21 CFR 211.160(b)(4)

21 CFR 211.165(a)

21 CFR 211.165(c)

21 CFR 211.165(e)

21 CFR 211.166(a)

21 CFR 211.188(b)(11)

21 CFR 211.194(a)(4)

21 CFR 211.22(d)

21 CFR 211.25(a)

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Record Information

Company

Seaway Pharma Inc.

Inspection Date

December 10, 2018

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: ff826c6d-3e52-4b1a-ae53-1055a6d6f857

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