C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 7—ENFORCEMENT POLICY › Subpart C—Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities

21 C.F.R. § 7.53

Recall status reports

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(a) The recalling firm is requested to submit periodic recall status reports to the appropriate Food and Drug Administration district office so that the agency may assess the progress of the recall. The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the Food and Drug Administration in each recall case; generally the reporting interval will be between 2 and 4 weeks.

(b) Unless otherwise specified or inappropriate in a given recall case, the recall status report should contain the following information:

(1) Number of consignees notified of the recall, and date and method of notification.

(2) Number of consignees responding to the recall communication and quantity of products on hand at the time it was received.

(3) Number of consignees that did not respond (if needed, the identity of nonresponding consignees may be requested by the Food and Drug Administration).

(4) Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.

(5) Number and results of effectiveness checks that were made.

(6) Estimated time frames for completion of the recall.

(c) Recall status reports are to be discontinued when the recall is terminated by the Food and Drug Administration.

Notes of Decisions
Cited in 2 cases, 2018–2018 · leading case: Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc., 328 F. Supp. 3d 824 (E.D. Ill. 2018).
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Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc., 328 F. Supp. 3d 824 (E.D. Ill. 2018). “42 ; 21 C.F.R. § 7.53 . This is not to say that the high costs of a purported agreement to initiate product recalls necessarily render the existence of the agreement implausible, per se.”
Washington Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc. (N.D. Ill. 2018). “42 ; 21 C.F.R. § 7.53 . This is 13 The defendants point out as well that the complaint’s allegations about price increases are not robust.”
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