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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 507 - CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS / Subpart D - Withdrawal of a Qualified Facility Exemption / § 507.62 Issuance of an order to withdraw a qualified facility exemption.
§ 507.62 Issuance of an order to withdraw a qualified facility exemption.

(a) An FDA District Director in whose district the qualified facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), or an FDA official senior to either such Director, must approve an order to withdraw the exemption before the order is issued.

(b) Any officer or qualified employee of FDA may issue an order to withdraw the exemption after it has been approved in accordance with paragraph (a) of this section.

(c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in charge of the facility.

(d) FDA must issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order.

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