FDA Inspection 1089185 - Octapharma Plasma, Inc. - May 09, 2019

FDA Inspection 1089185 for Octapharma Plasma, Inc. on May 09, 2019. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1089185 for Octapharma Plasma, Inc. on May 09, 2019. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 606.100(b)

21 CFR 606.170(a)

21 CFR 610.41

21 CFR 610.46(a)(2)

21 CFR 630.15(b)(6)

21 CFR 630.30(b)(1)

21 CFR 640.69(b)

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Record Information

Company

Octapharma Plasma, Inc.

Inspection Date

May 9, 2019

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: f87985e4-a3e3-46b7-b8b5-fedd7caade3e

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