FDA WARNING_LETTER - Red Oak Instruments, LLC - July 26, 2024

FDA WARNING_LETTER for Red Oak Instruments, LLC on July 26, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Red Oak Instruments, LLC on July 26, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 803.17(a)(1)

21 CFR 820.80(d)

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

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

21 CFR 803.18(b)(1)(i)

21 CFR 803.17(a)(3)

21 CFR 888.1240

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

21 CFR 820.30(i)

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Record Information

Company

Red Oak Instruments, LLC

Inspection Date

July 26, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 031bbb08-a560-4eec-b2a5-4e2c1343c503

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