Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry

Advarra, Incorporated, a company providing research review and compliance services, submitted comments supporting the draft guidance on responding to FDA Form 483 observations. They propose specific technical revisions, including adding footnotes for disagreements, clarifying terminology like CAPA and RCA, and suggesting additional bullet points to improve the clarity and practical application of the guidance for manufacturing facilities.

Vioela Respress, representing Respress Solutions LLC, supports the draft guidance but requests clarification on how it applies to Contract Development and Manufacturing Organizations (CDMOs). The commenter argues that because CDMOs often require coordination with sponsor companies for risk assessments and CAPA commitments, the guidance should explicitly acknowledge that multi-party coordination is a reasonable basis for submitting interim responses.