Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1On March 3, 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 e-mail address provided in your registration file. This request ultimately went unanswered. A second request was sent via e-mail on March 16, 2023, followed by an attempted contact by telephone with your registered U.S. Agent on April 12, 2023, regarding this matter. The Agency sent a follow-up written request for such records and other information on April 17, 2023. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.