Warning letterPosted August 12, 2025
FDA warning letter to Spectra Therapy, LLC
CGMP/QSR/Medical Devices/Adulterated
FDA posted a warning letter to Spectra Therapy, LLC on August 12, 2025; the letter is dated July 22, 2025. Subject: CGMP/QSR/Medical Devices/Adulterated. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Spectra Therapy, LLC
- Subject
- CGMP/QSR/Medical Devices/Adulterated
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-07-22
- Posted by FDA
- 2025-08-12
- Source
- FDA warning letters ↗
CFR cited
The record cites 20 sections of 21 CFR Parts 801, 803, 807, 820, 830 and 890.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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