Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1On September 9, 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, as did another email request sent on September 27, 2022. On October 3, 2022, you sent an email acknowledging FDA’s request, but did not respond to the 704(a)(4) request. FDA attempted to contact you by phone on November 16, 2022, and left a voicemail requesting that you provide a response by October 31, 2022. FDA also attempted to contact you by phone on September 6, 2023, and left a voicemail with your firm requesting a response within 24 hours. You failed to respond to these attempted communications or otherwise provide the requested records or other information.