FDA Inspection 1032515 - Spectra Therapy, LLC. - December 01, 2017

FDA Inspection 1032515 for Spectra Therapy, LLC. on December 01, 2017. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1032515 for Spectra Therapy, LLC. on December 01, 2017. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17

21 CFR 820.100(a)

21 CFR 820.198(a)

21 CFR 820.30(a)

21 CFR 820.50

21 CFR 820.80(b)

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Record Information

Company

Spectra Therapy, LLC.

Inspection Date

December 1, 2017

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: b8a7eb38-9a18-44a5-964e-c4bc3154c131

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