How to read these records

The classification

• NAI — No Action Indicated: no objectionable conditions or practices were found, or they do not justify further action.
• VAI — Voluntary Action Indicated: objectionable conditions were found, but the FDA is not prepared to take or recommend regulatory action.
• OAI — Official Action Indicated: regulatory or administrative action is recommended.

The classification is the FDA's, made after the inspection. One inspection can cover several product areas; this site shows its most serious classification.

Form 483

At the close of an inspection, the investigator may issue a Form FDA 483 listing observations. It is not a final agency determination of a violation, and firms often respond and correct. The FDA posts citations for part of its inspections only: an inspection without posted citations is not proof that none were made.

What the files cover

Inspections from fiscal year 2009 to 2026 as published on the FDA Data Dashboard, identified by FEI (FDA Establishment Identifier). Compliance actions (warning letters, injunctions, seizures) are shown for inspected firms. Firms named after a person are searchable but not listed on any page.