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    FDA 483 Observation + Warning Letter response template

    Use this free template to provide a structured and clear response to the FDA regarding a 484 Observation or Warning Letter received after an inspection.  

    Download for free
    FDA 483 Observation and Warning Letter response template | Scilife

    What’s inside?

    Created by our Knowledge Manager, this template will help you:

    • Formally address and acknowledge receipt of FDA’s observations with an editable cover letter
    • Craft the body of your response and present detailed observations and responses
    • Showcase underlying systematic improvements that go beyond individual issues
    • Include relevant evidence and documentation
    • Establish a follow-up plan and demonstrate ongoing commitment to compliance
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