Code of Federal Regulations Title 21. Food and Drugs § 21.900.16 Appeals of denials of certification

(1) The facility will not be operated in accordance with standards established under § 900.12;

(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.

(c)(1) If FDA denies an application for certification by a facility 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.

(2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of § 900.15(d).