Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1This request went unanswered, as did numerous telephone calls from the Agency regarding this matter, so the Agency sent a follow-up written request for such records and other information by certified return-receipt mail on May 6, 2021. You failed to respond to these attempted communications or otherwise provide the requested records or other information.