更多关于婴儿配方粉的法规,请详见美国FDA 21 CFR 第107部分关于婴儿配方粉的法规汇总。
§ 107.230 Elements of an infant formula recall.
A recalling firm shall conduct an infant formula recall with the following elements:
(a) The recalling firm shall evaluate in writing the hazard to human health associated with the use of the infant formula. This health hazard evaluation shall include consideration of any disease, injury, or other adverse physiological effect that has been or that could be caused by the infant formula and of the seriousness, likelihood, and consequences of the diseases, injury, or other adverse physiological effect. The Food and Drug Administration will conduct its own health hazard evaluation and promptly notify the recalling firm of the results of that evaluation if the criteria for recall under §107.200 have been met.
(b) The recalling firm shall devise a written recall strategy suited to the individual circumstances of the particular recall. The recall strategy shall take into account the health hazard evaluation and specify the following: The extent of the recall; if necessary, the public warning to be given
(c) The recalling firm shall promptly notify each of its affected direct accounts
(d) If the infant formula presents a risk to human health, the recalling firm shall request that each establishment, at which such infant formula is sold or available for sale, post at the point of purchase of such formula a notice of such recall at such establishment. The notice shall be provided by the recalling firm after approval of the notice by the Food and Drug Administration. The recalling firm shall also request that each retail establishment maintain such notice on display until such time as the Food and Drug Administration notifies the recalling firm that the agency considers the recall completed.
(e) The recalling firm shall furnish promptly to the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chapter, as they are available, copies of the health hazard evaluation, the recall strategy, and all recall communications (including, for a recall under §107.200, the notice to be displayed at retail establishments) directed to consignees, distributors, retailers, and members of the public.
[54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004]