FDA Warning Letters, 483s and Recalls: November 2026
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
No warning letters outside tobacco are recorded for this month yet.
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
No OAI inspections are recorded for this month yet.
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
No inspection citations are recorded for this month yet.
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
No Class I recalls are recorded for this month yet.
Check one company
See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.