FDA Warning Letters, 483s and Recalls: July 2018

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.

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

Showing the latest 100 of 512.

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.