FDA WARNING_LETTER - Diasol, Inc - August 19, 2025

FDA WARNING_LETTER for Diasol, Inc on August 19, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Diasol, Inc on August 19, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 CFR 803.17(a)(1)

21 CFR 820.80(d)

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

21 CFR 803.20(c)(1)

21 CFR 803.56

21 CFR 801.40(a)(2)

21 CFR 820.50(a)

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

21 CFR 803.17(a)(3)

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Record Information

Company

Diasol, Inc

Inspection Date

August 19, 2025

Product Type

devices

Office

Center for Devices and Radiological Health

People

ID: d4a4176e-a163-4a26-b8c4-3d2153f626c6

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