Drugs · Jun 8, 2023

Safe Chain Solutions, LLC

3 extracted findings

FDA source excerpt, selected passage

Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA (FD&C Act Section 582(c)(4)(A) & (B)).

FDA published a close-out letter on Mar 17, 2025. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Selected FDA passages, not the complete letter.

Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA (FD&C Act Section 582(c)(4)(A) & (B)).

Your firm failed to maintain records of suspect product investigations (FD&C Act Section 582(c)(4)(A)(iii)).

Your firm failed to respond to a notification of illegitimate product (FD&C Act Section 582(c)(4)(B)(iii)).

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