21 CFR § 58.206 - Final order on disqualification.

---
identifier: "/us/cfr/t21/s58.206"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 58.206 - Final order on disqualification."
title_number: 21
title_name: "Food and Drugs"
section_number: "58.206"
section_name: "Final order on 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"
---


# 58.206 Final order on disqualification.

(a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, makes the findings required in § 58.202, he shall issue a final order disqualifying the facility. Such order shall include a statement of the basis for that determination. Upon issuing a final order, the Commissioner shall notify (with a copy of the order) the testing facility of the action.

(b) If the Commissioner, after a regulatory hearing or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, does not make the findings required in § 58.202, he shall issue a final order terminating the disqualification proceeding. Such order shall include a statement of the basis for that determination. Upon issuing a final order the Commissioner shall notify the testing facility and provide a copy of the order.