Title 21

SECTION 830.130

830.130 Suspension or revocation of the accreditation of an issuing agency.

§ 830.130 Suspension or revocation of the accreditation of an issuing agency.

FDA may suspend or revoke the accreditation of an issuing agency if FDA finds, after providing the issuing agency with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the issuing agency or any officer, employee, or other agent of the issuing agency:

(a) Has been guilty of misrepresentation or failure to disclose required information in obtaining accreditation;

(b) Has failed to fulfill the responsibilities outlined in § 830.120;

(c) Has failed to protect against conflicts of interest that may impede the issuing agency's ability to independently operate a fair and neutral identifier system;

(d) In the operation of the issuing agency, has engaged in any anticompetitive activity to restrain trade; or

(e) Has violated or aided and abetted in the violation of any regulation issued under section 510(e) or section 519(f) of the Federal Food, Drug, and Cosmetic Act.

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