21 C.F.R. § 58.206   Final order on disqualification.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Subpart K—Disqualification of Testing Facilities

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§ 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 evaulation 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.

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