FDA WARNING_LETTER - Acrostak Schweiz AG - June 15, 2023

FDA WARNING_LETTER for Acrostak Schweiz AG on June 15, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Acrostak Schweiz AG on June 15, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

21 CFR 807.81(a)(3)

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

21 CFR 803.50(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 U.S.C. 360(k)

21 U.S.C. 381(a)

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Record Information

Company

Acrostak Schweiz AG

Inspection Date

June 15, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 595e15fd-65d6-4d3f-9010-d16043196826

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