[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.14]

[Page 560-561]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 900--MAMMOGRAPHY--Table of Contents
 
             Subpart B--Quality Standards and Certification
 
Sec. 900.14  Suspension or revocation of certificates.

    (a) Except as provided in paragraph (b) of this section, FDA may 
suspend or revoke a certificate if FDA finds, after providing the owner 
or operator of the facility with notice and opportunity for an informal 
hearing in accordance with part 16 of this chapter, that the owner, 
operator, or any employee of the facility:
    (1) Has been guilty of misrepresentation in obtaining the 
certificate;
    (2) Has failed to comply with the standards of Sec. 900.12;
    (3) Has failed to comply with reasonable requests of the agency or 
the accreditation body for records, information, reports, or materials 
that FDA believes are necessary to determine the continued eligibility 
of the facility for a certificate or continued compliance with the 
standards of Sec. 900.12;
    (4) Has refused a reasonable request of a duly designated FDA 
inspector, State inspector, or accreditation body representative for 
permission to inspect the facility or the operations and pertinent 
records of the facility;
    (5) Has violated or aided and abetted in the violation of any 
provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or

[[Page 561]]

    (6) Has failed to comply with prior sanctions imposed by the agency 
under 42 U.S.C. 263b(h).
    (b) FDA may suspend the certificate of a facility before holding a 
hearing if FDA makes a finding described in paragraph (a) of this 
section and also determines that;
    (1) The failure to comply with required standards presents a serious 
risk to human health;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the violation or aiding and 
abetting of the violation was intentional or associated with fraud.
    (c) If FDA suspends a certificate in accordance with paragraph (b) 
of this section:
    (1) The agency shall provide the facility with an opportunity for an 
informal hearing under part 16 of this chapter not later than 60 days 
from the effective date of this suspension;
    (2) The suspension shall remain in effect until the agency 
determines that:
    (i) Allegations of violations or misconduct were not substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The facility's certificate is revoked in accordance with 
paragraph (d) of this section;
    (d) After providing a hearing in accordance with paragraph (c)(1) of 
this section, the agency may revoke the facility's certificate if the 
agency determines that the facility:
    (1) Is unwilling or unable to correct violations that were the basis 
for suspension; or
    (2) Has engaged in fraudulent activity to obtain or continue 
certification.