Comment from Czarina Vea
AnonymousSupportIndividual
Summary: Czarina Vea, a Quality Control Professional, supports the draft guidance but suggests several modifications to improve its effectiveness. The commenter proposes a "Two-Phase" reporting structure for complex observations to balance the 15-business-day deadline with thorough investigation requirements, recommends requiring a consultant's Scope of Work, and suggests a "Dual-Signatory Anchor" approach for executive and quality unit oversight.
Please see attached public comment on FDA-2025-D-1504 Draft Guidance "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection".