FDA WARNING_LETTER - Pairon Solutions LLC - July 14, 2021

FDA WARNING_LETTER for Pairon Solutions LLC on July 14, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Pairon Solutions LLC on July 14, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 352(a)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 807.39

21 U.S.C. 352(o)

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Record Information

Company

Pairon Solutions LLC

Inspection Date

July 14, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: bf62dcb2-96f7-4744-a3e6-363003b8140c

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