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FDA Seeks Comments on Recall Guidelines
November 28, 2011
1 Min Read
WASHINGTONThe U.S. Food and Drug Administration (FDA) is seeking comments on proposed FDA recall guidelines that have been published in the Federal Register and submitted to the Office of Management and Budget (OMB) for review and clearance.
Proposed guidelines include the following:
Recall Strategy. Request firms develop a recall strategy including provision for public warnings and effectiveness checks. Under this portion of the collection of information.
Firm Initiated Recall and Recall Communications. Request firms voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and tobacco to immediately notify the appropriate FDA district office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced,
distribution information, firms' recall strategy, and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm.
Recall Status Reports. Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This request only applies to firms with active recalls, and is estimated to be reported every two to four weeks.
Termination of a Recall. Provide the firms an opportunity to request in writing that FDA end the recall.
Comments are due on or before Dec. 23, 2011. Written comments can be sent to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: (202) 395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0249. Also include the FDA docket number found in brackets in the heading of this document.
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