FDA WARNING_LETTER - Baylab USA, LLC - January 31, 2024

FDA WARNING_LETTER for Baylab USA, LLC on January 31, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Baylab USA, LLC on January 31, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

21 CFR 801.40(a)(2)

21 CFR 820.50(a)

21 U.S.C. 331(q)(1)(B)

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

21 CFR 820.30(a)

21 CFR 830.320(b)

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

21 U.S.C. 321(h)

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Record Information

Company

Baylab USA, LLC

Inspection Date

January 31, 2024

Product Type

Devices

Office

Office of Health Technology 4 (Surgical and Infection Control Devices)

People

ID: 60620309-bb04-48c7-a2a4-c6c6d4950520

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