FDA Inspection 1208820 - Sonesta Medical AB - June 07, 2023

FDA Inspection 1208820 for Sonesta Medical AB on June 07, 2023. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1208820 for Sonesta Medical AB on June 07, 2023. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17

21 CFR 820.198(a)

21 CFR 820.30(c)

21 CFR 820.30(g)

21 CFR 820.30(i)

21 CFR 820.40

21 CFR 820.50

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Record Information

Company

Sonesta Medical AB

Inspection Date

June 7, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: 52ceec9e-d765-4135-9344-873d0c3ab44c

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