FDA Inspection 1325666 - Spectra Therapy, LLC. - July 08, 2026

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Record Details

This FDA Inspection record concerns Spectra Therapy, LLC., with an inspection on July 8, 2026, issued by the Detroit District Office, covering medical devices & rad health.

Company: Spectra Therapy, LLC.
Inspection Date: July 8, 2026
Product Type: Medical Devices & Rad Health
Office: Detroit District Office

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ID · ccfc0247-354e-400b-a361-5308a2d39b26

Violation Codes10

21 CFR 801.20(a)21 CFR 830.310(b)ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 6.2(b)ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.3.10ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 8.2.4ISO 13485:2016 Clause 8.2.6

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