Description
Section 305 of the Act states: "Before any violation of this Act is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding."
Scope & Applicability
Stakeholders
1Recipient of the report of criminal violation for institution of proceedings.
Related CFR Sections (3)
- 21CFR7.87§ 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.
(a) Records related to a section 305 opportunity for presentation of views constitute investigatory records for law enforcement purposes and may include inter- and intra-agency memorandums.Read full regulation →
- 21CFR7.85§ 7.85 Conduct of a presentation of views before report of criminal violation.
(a) The presentation of views shall be heard by a designated Food and Drug Administration employee. Other Food and Drug Administration employees may be present.Read full regulation →
- 21CFR7.84§ 7.84 Opportunity for presentation of views before report of criminal violation.