Common Mistakes to Avoid During Form 483 Compliance

 Medical device manufacturers receive observations (Form 483) and/or warning letters on completion of the USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMPs) such as the facility, equipment, processes, controls, products, employee practices or records.

Here are a few common mistakes to avoid when crafting your response to an FDA 483:

·         Giving vague or broad assurances

·         Responding too quickly to serious problems

·         Overwhelming investigators with irrelevant data

·         Exaggerating the implications of the changes

·         Responding with a rebuttal

IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy. The IZiel team in collaboration with the customer utilize an extensive & comprehensive methodologyto complete the remediation project. Our Onshore-Offshore Model with strong project management ensure deliveries with faster timelines, flexible resources and in a cost-effective manner.