FDA Inspection 1254551 - Nutek Orthopaedics, Inc. - November 19, 2024

FDA Inspection 1254551 for Nutek Orthopaedics, Inc. on November 19, 2024. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1254551 for Nutek Orthopaedics, Inc. on November 19, 2024. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 820.184

21 CFR 820.20(c)

21 CFR 820.22

21 CFR 820.25(b)

21 CFR 820.40

21 CFR 820.50

21 CFR 820.80(d)

21 CFR 830.300(a)

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Record Information

Company

Nutek Orthopaedics, Inc.

Inspection Date

November 19, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f75a7c14-8900-43fd-9522-eff03c20d99c

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