FDA WARNING_LETTER - Westlake IVF, LLC - May 31, 2019

FDA WARNING_LETTER for Westlake IVF, LLC on May 31, 2019. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Westlake IVF, LLC on May 31, 2019. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 1271.47(a)

21 CFR 1271.45-1271.90

21 CFR 1271.90(c)

21 CFR 1271.50(a)

21 CFR 1271

21 CFR 1271.60(a)

21 CFR 1271.155

21 CFR 1271.90(b)

21 CFR 1271.85(a)

21 CFR 1271.75(a)(1)

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Record Information

Company

Westlake IVF, LLC

Inspection Date

May 31, 2019

Product Type

Biologics

Office

Office of Biological Products Operations - Division I

People

Karlton T. Watson (Program Division Director)

ID: 315f61ba-dbf5-46d0-ae9a-cf5e92af0110

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