FDA WARNING_LETTER - Deymed Diagnostic s.r.o. - July 27, 2023

FDA WARNING_LETTER for Deymed Diagnostic s.r.o. on July 27, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Deymed Diagnostic s.r.o. on July 27, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.70(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.184

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Record Information

Company

Deymed Diagnostic s.r.o.

Inspection Date

July 27, 2023

Product Type

Devices

Office

Office of Health Technology 5 (Neurological and Physical Medicine Devices)

People

ID: 65a519c5-5e9d-41e6-8089-15fb4efdeb5e

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