§ 1.1445. Under what circumstances may FDA modify or revoke a waiver?
122 words·~1 min read·
/us/cfr/t21/s§ 1.1445A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
FDA may modify or revoke a waiver if we determine that:
(a)Compliance with the waived requirements would no longer impose a unique economic hardship on the individual entity or type of entity to which the waiver applies;
(b)The waiver could significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; or
(c)The waiver is otherwise contrary to the public interest.