FDA WARNING_LETTER - Fischer ANalysen Instrumente GmbH - November 04, 2022

FDA WARNING_LETTER for Fischer ANalysen Instrumente GmbH on November 04, 2022. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Fischer ANalysen Instrumente GmbH on November 04, 2022. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 803.18(b)(1)(i)

21 CFR 820.198

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 803

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

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Record Information

Company

Fischer ANalysen Instrumente GmbH

Inspection Date

November 4, 2022

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 3576b6e5-549f-4a13-9c39-bd89477e249e

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