Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Our records indicate that you have not registered or listed these devices for fiscal year 2026.
Issued · Posted by FDA
FDA published a close-out letter on Apr 2, 2026. The passages below are from the original warning letter.
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Our records indicate that you have not registered or listed these devices for fiscal year 2026.