Draft a Regulatory Compliance Memo evaluating FDA 21 CFR Part 111 dietary supplement GMP deviations observed during third-party audit of contract manufacturer producing encapsulated nootropic blends for clinical trial supply

Generate draft a regulatory compliance memo evaluating fda 21 cfr part 111 dietary supplement gmp deviations observed during third-party audit of contract manufacturer producing encapsulated nootropic blends for clinical trial supply for Other Professional, Scientific, and Technical Services industry

Other Professional, Scientific, and Technical Services

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Max size: 50MB

Upload the completed third-party GMP audit report identifying FDA 21 CFR Part 111 deviations
Provide contract manufacturer's name, address, FDA registration number, and scope of operations
List the specific nootropic compounds, dosages, and clinical trial phase for each encapsulated blend
Select the most severe FDA 21 CFR Part 111 deviations identified
Indicate the regulatory risk level based on deviation impact to clinical trial integrity
Specify the required response timeline based on regulatory obligations and clinical trial deadlines
List key stakeholders requiring the compliance memo (clinical operations, QA, regulatory affairs, legal, CRO)
Describe potential impact on ongoing clinical trial(s) from these GMP deviations
Reference similar FDA warning letters or 483 observations related to these deviation types for benchmarking CAPA
Select the format and detail level for the regulatory compliance memo

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Max size: 100MB

Attach supporting files such as batch records, release testing, photographs, or supplier certificates
Add any additional context, client-specific requirements, or coordination notes for the compliance memo