FDA Form 483 or Warning Letter Response

The dreaded Form 483 (and/or Warning Letter) from the US Food and Drug Administration (FDA) is bad news for any medical device manufacturer.

Form 483 is issued by the FDA after an on-site inspection whenever it is believed that your quality system is deficient. Form 483 compares your operational GMP quality system with the FDA inspector’s interpretation of the regulations.

If severe faults are found, you will receive a Warning Letter based on the findings of Form 483 as exemplified by the field inspector.

Form 483 requires quick action on your part. It is essential to define your course of action so as to remedy the faults asap. Once this is done, you will need to provide a detailed response for each problematic item you addressed. Note that a timely and efficient response is vitally important.

Techlink International can help you respond to a FDA Form 483 or Warning Letter.

When things are not as streamline as you would like them to be, we at TechLink International are here to help you reply effectively to an FDA 483. Together we will make sure that your GMP quality system is utterly compliant with FDA requirements. Here is a glimpse of what we can do for you:

Assess and analyze the results of the FDA 483 and/or of the Warning Letter. Set-up the right set of steps to be taken by your company. Offer corrective measures to be implemented right away into your quality system. Help you decide on the right time frame to comply with FDA regulations. Provide assistance with regard to the implementing of the corrective measures against FDA Form 483. Assist in implementing corrective actions in response to FDA Form 483. Answer all queries from the FDA and reply to all your questions during the time of the implementing of the corrective measures.