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For Part C, is an individual summary report required for each audit, or is a singular summary audit report for all audits required? For the summary report(s), is there an expectation for the manufacturer to provide samples of the actual audit reports to support the summary reports?

What qualifications must be demonstrated by the third party who summarizes the reports? What's the difference between a summary developed by the manufacturer versus a summary created by a third party [both are based on audit reports]. If the manufacturer outsources the summary creation to a third party, why do they need qualifications but the manufacturer does not?

Please clarify the report requirements in Part C, including whether a singular report (and  whether supporting documentation to confirm how report was aggregated is required), or individual summaries are required, and if samples of the full audit reports are required.

Clarify qualifications.