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 4, 2021. Delivery was confirmed by your signature, but you failed to respond to these attempted communications or otherwise provide the requested records or other information.
Passage 2It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).
Passage 3Fracking operations typically involve multiple chemicals that could be harmful to patients if they were to contaminate drugs, such as your hand sanitizers.