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. A second request was sent via e-mail on August 27, 2021, followed by a telephone conversation with your registered U.S. Agent on October 26, 2021, regarding this matter. The Agency sent a follow-up written request for such records and other information on November 24, 2021. 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.
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 3Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.