FDA WARNING_LETTER - Genomma Lab USA, Inc. - April 19, 2022

FDA WARNING_LETTER for Genomma Lab USA, Inc. on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Genomma Lab USA, Inc. on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 355h

21 U.S.C. 331(a)

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

21 U.S.C. 355h(a)(4)

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

21 U.S.C. 355

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

21 U.S.C. 352(ee)

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Record Information

Company

Genomma Lab USA, Inc.

Inspection Date

April 19, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Carolyn E. Becker

ID: edc91615-357c-4e60-97a0-e03fba7c0651

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