FDA Inspection 1216260 - SMITHWORKS, INC. - August 29, 2023

FDA Inspection 1216260 for SMITHWORKS, INC. on August 29, 2023. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1216260 for SMITHWORKS, INC. on August 29, 2023. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17

21 CFR 820.100(a)

21 CFR 820.181

21 CFR 820.198(a)

21 CFR 820.22

21 CFR 820.30(i)

21 CFR 820.80(a)

21 CFR 820.90(a)

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Record Information

Company

SMITHWORKS, INC.

Inspection Date

August 29, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f7c55aff-991b-48d7-9977-5e78a054dd7b

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