FDA WARNING_LETTER - ASP Global, LLC. - August 01, 2025

FDA WARNING_LETTER for ASP Global, LLC. on August 01, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ASP Global, LLC. on August 01, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 CFR 809.10(b)(8)(i)

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

FD&C Act 520(g)

21 CFR 806.2(d)

21 CFR 801.119

FD&C Act 502(o)

FD&C Act 510(k)

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

FD&C Act 501(h)

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Record Information

Company

ASP Global, LLC.

Inspection Date

August 1, 2025

Product Type

Devices

Office

Office of Regulatory Programs

People

ID: 75034c87-55c3-4092-888e-986adb8b7beb

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