DIAZ Trade Law

Customs & International Trade Law Expert

Dealing with FDA Enforcement Issues

Call 305-456-3830
An FDA inspection can have devastating consequences if a company is not prepared. Inspections can lead to a Form 483 identifying “observations” noted by the FDA, that must be fixed. Typical observations are related to current good manufacturing practices, adulteration and misbranding issues. If the observations are not properly addressed, they can lead to Warning Letters, inclusion on Import Alert lists, or even a consent decree by the FDA to seize product, or shut down your facility.

Did you receive a Notice that looks like this from FDA after an FDA inspection?

(If so, we can help. See below)

Warning Letter2

What Does This Notice Mean?

Your company has 15 days to address the observations and identify why the “observation” occurred, and more importantly, how you will fix it.

How Can Diaz Trade Law Help?

Diaz Trade Law has successfully assisted many companies in preparing for an inspection, reviewing and responding to 483’s when issued, and mitigating the consequences of them.


Call 305-456-3830

Note: If you have documents you would like us to review, please email docs@DiazTradeLaw.com

diaz trade law msi global alliance
diaz trade law Chambers Global Lawyer Ranking
diaz trade law Chambers 2021
diaz trade law Chambers 2020
Diaz Trade Law Goldman Sachs
Diaz Trade Law Women In Trade
diaz trade law florida legal elite
diaz trade law super lawyers
As Seen On:
diaz trade law
diaz trade law
diaz trade law
diaz trade law
diaz trade law

Diaz Trade Law (DTL) remains
available during Coronavirus.

Learn about DTL's Operations During the Coronavirus HERE.


Want to discuss a new or existing matter? Contact DTL at info@diaztradelaw.com or 305-456-3830.