Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to respond to requests for information from Federal and State Officials (FD&C Act Section 582(c)(1)(C)).
Passage 2Your firm failed to collect and maintain transaction information and transaction statements (FD&C Act Section 582(c)(1)).
Passage 3Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA. (FD&C Act Sections 582(c)(4)(A) and (B)).