WARNING LETTER

Sonesta Medical ABJune 7, 2023

FDA WARNING_LETTER - Sonesta Medical AB - June 07, 2023

FDA WARNING_LETTER for Sonesta Medical AB on June 07, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sonesta Medical AB on June 07, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.50(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 820.30(c)

21 U.S.C. 351(h)

21 CFR 820.30(g)

21 CFR 820.40

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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

People

ID: e64818d2-e29e-4938-accf-a97fc8ec5b29

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WARNING LETTER

Sonesta Medical ABJune 7, 2023

FDA WARNING_LETTER - Sonesta Medical AB - June 07, 2023

FDA WARNING_LETTER for Sonesta Medical AB on June 07, 2023. Product: Devices. Access full analysis and detailed observations.

View on Dashboard

One-time purchase from the GKS catalog. Lifetime access in your library. Single documents and full company profiles available. All sales final.

Record Summary

FDA WARNING_LETTER for Sonesta Medical AB on June 07, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.50(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 820.30(c)

21 U.S.C. 351(h)

21 CFR 820.30(g)

21 CFR 820.40

Get More Insights

Access our comprehensive regulatory intelligence platform to analyze patterns, track compliance trends, and stay ahead of regulatory changes.

1.5M+ regulatory data points

Real-time compliance monitoring

Interactive analytics dashboard

Looking for more records? Our platform provides access to thousands of similar regulatory documents with advanced search and filtering capabilities.

Record Information

Company

Sonesta Medical AB

Inspection Date

June 7, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e64818d2-e29e-4938-accf-a97fc8ec5b29

View on Dashboard

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.

Try KeyPedia Today

Explore our real use cases and discover our features in depth.

Subscribe to our newsletter

Get the latest updates and insights delivered to your inbox