FDA WARNING_LETTER - Spectra Therapy, LLC. - September 13, 2024

FDA WARNING_LETTER for Spectra Therapy, LLC. on September 13, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Spectra Therapy, LLC. on September 13, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 CFR 820.22

21 CFR 803.17(a)(1)

21 CFR 820.80(d)

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

21 CFR 820.90

21 CFR 803.20(c)(1)

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

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

21 CFR 820.50(a)(1)

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Record Information

Company

Spectra Therapy, LLC.

Inspection Date

September 13, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: dd880000-b732-462f-8924-8bb1b4216fed

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