FDA WARNING_LETTER - 21st Century Scientific Inc - September 12, 2018

FDA WARNING_LETTER for 21st Century Scientific Inc on September 12, 2018. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for 21st Century Scientific Inc on September 12, 2018. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 807.81(a)(3)

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

21 CFR 803.17(a)(3)

21 CFR 803.3

21 CFR 803.50(a)

21 CFR 803.50(a)(1)

21 U.S.C. 321(h)

21 CFR 803.17(a)(2)

21 U.S.C. 360(k)

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Record Information

Company

21st Century Scientific Inc

Inspection Date

September 12, 2018

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 328f177f-48b1-4db0-93f6-16f8925d1383

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