[ FDA WARNING LETTERS ]

What the FDA is calling out, in writing.

Warning Letters are the FDA’s formal notice that a firm is significantly out of compliance — inspection-readiness gold. SPEQ tracks every letter back to 2021 by date and recipient, and adds the issuing office, subject and a link to the full text for the recent window FDA still publishes in full.

2,335
Letters tracked
Oct 27, 2026
Most recent
8
Issuing offices
across the 129 letters FDA still publishes in full; older rows carry a date and recipient only.
Center for Drug Evaluation and Research (CDER) · 60Office of Inspections and Investigations · 19Human Foods Program · 15Center for Devices and Radiological Health · 12Center for Veterinary Medicine · 12

How to use this library

Search the recipient or subject, or filter by issuing office: CDER writes to drug manufacturers, CDRH to device makers. Recent letters open with the subject and a link to FDA’s own published letter.

Warning letters are FDA records reproduced as published; SPEQ adds no interpretation. A letter states the Agency’s position at the time of issue and does not by itself establish a final determination. Older archive rows carry a date and recipient only.

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This list holds the newest 60 of 2,335 letters SPEQ tracks; search, filters, order and export apply to these 60. Every letter has its own page.

60 warning letters
Newest first
COMPLETE INDEX — ALL 60 WARNING LETTER

Every count on this page is derived from the fda_warning_letters table at render — none is a literal. Follow each source link for FDA’s authoritative letter.

Source: U.S. FDA Warning Letters (fda.gov), scraped and refreshed daily. Warning letters are FDA records reproduced as published — SPEQ adds no interpretation. The archive builds forward from the first scan.