FDA Inspection 799153 - Pensar Medical LLC - September 12, 2012

FDA Inspection 799153 for Pensar Medical LLC on September 12, 2012. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 799153 for Pensar Medical LLC on September 12, 2012. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.50(a)(2)

21 CFR 820.100(a)

21 CFR 820.100(b)

21 CFR 820.198(c)

21 CFR 820.30(g)

21 CFR 820.90(a)

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Record Information

Company

Pensar Medical LLC

Inspection Date

September 12, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f9bf3d75-85e8-4a4f-8043-7e4f3636280e

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