Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1It 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). Because your 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 listed as having been manufactured at your facility.