21 CFR § 58.204 - Notice of and opportunity for hearing on proposed disqualification.

---
identifier: "/us/cfr/t21/s58.204"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 58.204 - Notice of and opportunity for hearing on proposed disqualification."
title_number: 21
title_name: "Food and Drugs"
section_number: "58.204"
section_name: "Notice of and opportunity for hearing on proposed disqualification."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "58"
part_name: "GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n."
regulatory_source: "43 FR 60013, Dec. 22, 1978, unless otherwise noted."
cfr_part: "58"
---


# 58.204 Notice of and opportunity for hearing on proposed disqualification.

(a) Whenever the Commissioner has information indicating that grounds exist under § 58.202 which in his opinion justify disqualification of a testing facility, he may issue to the testing facility a written notice proposing that the facility be disqualified.

(b) A hearing on the disqualification shall be conducted in accordance with the requirements for a regulatory hearing set forth in part 16 of this chapter.