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 methodology to 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.
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