FDA WARNING_LETTER - Mihon Corp. d/b/a VitalityVita and Boulla, LLC - November 08, 2024

FDA WARNING_LETTER for Mihon Corp. d/b/a VitalityVita and Boulla, LLC on November 08, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Mihon Corp. d/b/a VitalityVita and Boulla, LLC on November 08, 2024. 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. 331(a)

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

21 U.S.C. 352(a)

21 U.S.C. 353(b)(1)

21 CFR 201.100(c)(2)

21 CFR 201.5

21 U.S.C. 321(ff)(3)(B)(i)

21 U.S.C. 321(ff)(3)(B)(ii)

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Record Information

Company

Mihon Corp. d/b/a VitalityVita and Boulla, LLC

Inspection Date

November 8, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Tina Smith (Director)

ID: b35a0e67-b406-4028-8703-65e1e90112d4

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