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Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication

Responses that lack root cause analysis CAPA without clear owners or timelines We will correct this, promises with no evidence Missing documentation to support completed actions Key lessons Always approach a 483 as if it were a regulatory submission

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Success in EB applications could also inform development strategies for T4 in other rare diseases characterized by impaired tissue repair or maintenance, expanding the therapeutic impact of this versatile peptide beyond more common indications