Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1On March 17, 2023, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact email address provided in your registration file. This request went unanswered.
Passage 2On April 19, 2023, you responded stating that you were “not prepared to allow the FDA to audit and inspect” your firm.