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)
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.