Comment from Consumer Healthcare Products Association (CHPA)
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Summary: The Consumer Healthcare Products Association (CHPA) supports the FDA's effort to provide guidance on responding to Form 483 observations but urges the agency to ensure the guidance is risk-based and practical. They specifically recommend allowing for phased responses, interim controls, and tailored CAPA commitments to balance patient safety with the need to maintain supply continuity for over-the-counter products.
CHPA Comments: Responding to FDA Form 483 Observations at the Conclusion of a Drug cGMP Inspection: Draft Guidance for Industry