FDA WARNING_LETTER - Iso-Tex Diagnostics, Inc. - February 10, 2023

FDA WARNING_LETTER for Iso-Tex Diagnostics, Inc. on February 10, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Iso-Tex Diagnostics, Inc. on February 10, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211.42(a)

21 CFR 211.160(b)

21 CFR 211.42(c)(10)(iv)

21 CFR 211

21 CFR 211.42(c)(10)(v)

21 CFR 210

21 U.S.C. 351(a)(2)(B)

21 U.S.C. 356C(b)

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Record Information

Company

Iso-Tex Diagnostics, Inc.

Inspection Date

February 10, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

Monica R. Maxwell (Program Division Director)

ID: 334e4998-deee-4d28-bfd7-da09eaa4bc1f

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