FDA WARNING_LETTER - The Richline Group Inc - April 16, 2025

FDA WARNING_LETTER for The Richline Group Inc on April 16, 2025. Product: Other. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for The Richline Group Inc on April 16, 2025. Product: Other. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 U.S.C. 360j(g)

FD&C Act 520(g)

21 CFR 801.40(a)(2)

21 U.S.C. 331(q)(1)(B)

FD&C Act 502(o)

FD&C Act 510(k)

21 U.S.C. 352(t)(2)

FD&C Act 501(h)

21 CFR 820.30(a)

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Record Information

Company

The Richline Group Inc

Inspection Date

April 16, 2025

Product Type

Other

Office

Center for Devices and Radiological Health

People

Matthew G. Hillebrenner

ID: f7c35294-420f-4ed0-bcdc-033c8a38d115

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