FDA WARNING_LETTER - Kleenhanz, LLC - April 19, 2022

FDA WARNING_LETTER for Kleenhanz, LLC on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Kleenhanz, LLC on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 355h

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 321(g)(1)(B)

21 CFR 201.128

21 U.S.C. 321(g)(1)(C)

21 U.S.C. 352(ee)

21 CFR 201.66(b)(2)

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Record Information

Company

Kleenhanz, LLC

Inspection Date

April 19, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Carolyn E. Becker

ID: 32407a50-6862-4724-8a6a-60be8a10f803

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