FDA EIR - Presbyterian/St. Luke's Medical Center Donor Services - January 26, 2017

FDA EIR for Presbyterian/St. Luke's Medical Center Donor Services on January 26, 2017. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Presbyterian/St. Luke's Medical Center Donor Services on January 26, 2017. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 630.6

21 CFR 630.40(b)(2)

21 CFR 606.100(c)

21 CFR 211.194(a)(8)

21 CFR 640.21(g)

21 CFR 606.100(b)

21 CFR 606.160(a)(1)

21 CFR 640.25(a)

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Record Information

Company

Presbyterian/St. Luke's Medical Center Donor Services

Inspection Date

January 26, 2017

Product Type

Biologics

Office

Denver District Office

People

ID: 5a3af212-e013-4e8d-9f9d-964f869a6eb7

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