21 CFR 900.16 - Appeals of denials of certification.
(a) The appeals procedures described in this section are available only to facilities that are denied certification by FDA after they have been accredited by an approved accreditation body. Appeals for facilities that have failed to become accredited are governed by the procedures set forth in § 900.15.
(2) The facility will not permit inspections or provide access to records or information in a timely fashion; or
(3) The facility has been guilty of misrepresentation in obtaining the accreditation.
(1) If FDA denies an application for certification by a faciity that has received accreditation from an approved accreditation body, FDA shall provide the facility with a statement of the grounds on which the denial is based.