Warning letterPosted July 22, 2025
FDA warning letter to Leltek Inc.
CGMP/QSR/Medical Devices/Adulterated
FDA posted a warning letter to Leltek Inc. on July 22, 2025; the letter is dated July 17, 2025. Subject: CGMP/QSR/Medical Devices/Adulterated. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Leltek Inc.
- Subject
- CGMP/QSR/Medical Devices/Adulterated
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-07-17
- Posted by FDA
- 2025-07-22
- Source
- FDA warning letters ↗
CFR cited
The record cites 14 sections of 21 CFR Parts 803 and 820.
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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From FDA warning letters. The record may have changed since it was read.
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