Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1On November 15, 2022, 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 e-mail address provided in your registration file. This request went unanswered. A second request was sent via e-mail on November 23, 2022, followed by a telephone conversation with your registered U.S. Agent on December 2, 2022, regarding this matter; the U.S. Agent indicated that they no longer represent your firm. The Agency sent a follow-up written request for such records and other information to your firm on December 3, 2022. Delivery to you was confirmed by the shipper, but you failed to respond to these