Food Drug Administration 483 Response
Prevent a Warning Letter.
There is no time to waste! You have 15 business days to respond before a public Warning Letter is issued.
15Days
FDA Form 483
Companies must respond to the FDA 483 in writing with their corrective action plan within 15 working days and then implement that corrective action plan expeditiously.
When is an FDA Form 483 issued?
An FDA Form 483 is issued to the management of a facility at the conclusion of an inspection. when an investigator has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic Act, they will issue this form.
The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.
Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation?
The observations may seem straightforward, but some may encompass large areas of quality within your organization. Companies must respond to the FDA 483 in writing with their corrective action plan within 15 working days and then implement that corrective action plan expeditiously. The initial response should be written in a way that confirms to FDA that you have taken some immediate actions and have a solid plan to address all violations in the 483. If the response to the 483 is insufficient, the FDA will likely issue a Warning Letter which is published on their website for the public to see. Once the Warning Letter goes live it can take months and in some cases years to close it out.
Don’t waste any more time! Schedule a free consultation call with our attorneys before time runs out!
Getting a 483 from the FDA can be nerve-wracking, but not to worry. Let our team guide your response strategy and draft your response so you can prevent a public warning letter.
Find out how we can help you
We strive to ensure that our clients are educated about the processes of becoming compliant and understand our role in the process. Hiring an FDA regulatory attorney can make all the difference when ensuring compliance.
Let us provide you a free consultation on us today ($99 value)