FDA WARNING_LETTER - Banco Vida Corp. - September 18, 2019

FDA WARNING_LETTER for Banco Vida Corp. on September 18, 2019. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Banco Vida Corp. on September 18, 2019. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 1271.47(a)

21 CFR 1271.230(a)

21 CFR 1271.65(b)(2)

21 CFR 1271.195(a)

21 CFR 1271.160(b)(6)

21 CFR 1271.80(c)

21 CFR 1271.220(a)

21 CFR 1271.75(a)

21 CFR 1271.65(b)(1)

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Record Information

Company

Banco Vida Corp.

Inspection Date

September 18, 2019

Product Type

Biologics

Office

Office of Biological Product Operations

People

Elizabeth A. Waltrip (Program Division Director)

ID: 30f4c14d-0486-4d6d-a6c8-36966a0be22f

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