Mandatory Recall Draft Guidance

FDA’s mandatory food recall authority went into effect when FSMA was enacted on January 4, 2011. Section 423 of the FD&C Act, as added by Section 206 of FSMA, gives FDA the authority to order a responsible party to recall an article of food where FDA determines that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act [21 U.S.C. § 342] or misbranded under section 403(w) of the FD&C Act [21 U.S.C. § 343(w)] and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

Click Here to read full document

Comments are closed.