FDA Inspection 771123 - Hemarus, LLC - March 02, 2012

FDA Inspection 771123 for Hemarus, LLC on March 02, 2012. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 771123 for Hemarus, LLC on March 02, 2012. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 606.100(c)

21 CFR 606.160(a)(1)

21 CFR 606.160(b)

21 CFR 606.160(e)(1)

21 CFR 606.20(b)

21 CFR 606.60(a)

21 CFR 610.46(a)(1)

21 CFR 640.63(a)

21 CFR 640.65(b)(1)(i)

21 CFR 640.65(b)(2)(i)

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Record Information

Company

Hemarus, LLC

Inspection Date

March 2, 2012

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: f6ec9246-7418-4142-85b3-8ae1ec8fc978

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