FDA WARNING_LETTER - Rechon Life Science AB - September 06, 2024

FDA WARNING_LETTER for Rechon Life Science AB on September 06, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Rechon Life Science AB on September 06, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

FD&C Act 801(a)(3)

FD&C Act 501(a)(2)(B)

21 CFR 211.58

21 CFR 211

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

21 CFR 210

21 CFR 211.192

21 U.S.C. 381(a)(3)

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

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Record Information

Company

Rechon Life Science AB

Inspection Date

September 6, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: ec7b8f99-2090-44b2-b048-fe367628faae

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