YourEncore Insights - Life Sciences

Victor Chance and Judith Meritz

Recent Posts

FDA 483 Response: Four Tips to Avoid a Warning Letter

Posted by Victor Chance and Judith Meritz on 8/25/16 12:05 PM

The receipt of a 483 at the conclusion of a facility inspection notifies a company of conditions the FDA believes are in violation of the Food, Drug & Cosmetic Act. If 483s are not properly addressed, the FDA can take further enforcement action to protect the public health – including issuing Warning Letters. Warning Letters not only indicate potential risks to patients, but also bring unwanted publicity, erode patient trust, and potentially restrict the approval of future products significantly impacting revenue. Therefore, companies must know how to mount a competent response.

Read More

Topics: Quality & Safety, Medical Device, FDA