Radiation-Emitting Products

Suspension or Revocation of Certificates

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(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 section 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 section 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

(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 that 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.

Page Last Updated: 08/11/2014
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