FDA WARNING_LETTER - Byd Precision Manufacture Co., Ltd - May 26, 2023

FDA WARNING_LETTER for Byd Precision Manufacture Co., Ltd on May 26, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Byd Precision Manufacture Co., Ltd on May 26, 2023. 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 820.30

21 CFR 803.3

21 CFR 803.50(a)

21 CFR 803.12(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 820.75(a)

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Record Information

Company

Byd Precision Manufacture Co., Ltd

Inspection Date

May 26, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Binita S. Ashar (Director)

ID: 6f1b269d-ab4b-43c7-a64b-4a2a7aea6986

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