FDA Inspection 1228647 - Baylab USA, LLC - January 31, 2024

FDA Inspection 1228647 for Baylab USA, LLC on January 31, 2024. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1228647 for Baylab USA, LLC on January 31, 2024. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 801.20(a)

21 CFR 803.17

21 CFR 820.100(a)

21 CFR 820.22

21 CFR 820.25(b)

21 CFR 820.30(a)

21 CFR 820.50

21 CFR 820.75(a)

21 CFR 830.310(b)

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Record Information

Company

Baylab USA, LLC

Inspection Date

January 31, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: 84357b46-0a99-4d01-87f4-a015c5135c92

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