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FDA Warning Letter Explorer
FDA warning letter · Drugs

Safe Chain Solutions, LLC

Issued · Posted by FDA

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

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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)).

Passage 2

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

Passage 3

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