The Food and Drug Administration is adding a new chapter to its draft guidance on hazard analysis and risk-based preventive controls regulations for human food. The new Chapter 14 on recall plans is meant to help food establishments establish and implement a written recall plan, as required under the preventive controls regulations. Comments must be submitted by Feb. 4, 2020, to ensure FDA sees them before starting work on its upcoming final guidance document, the agency said in a notice.
On Oct. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration on Oct. 7 announced it has created a new list of records required by the Foreign Supplier Verification Program regulations. The list Is intended to “help importers determine the FSVP records they should develop and maintain,” FDA said in an emailed announcement. “During an FSVP inspection, the FDA investigator will review the importer’s records to determine their compliance with the FSVP regulation,” FDA said. The list is organized based on the sections of the FSVP regulations “so that importers can readily determine the required records for the sections that apply to them,” the agency said. “Importers should note that not every record on the list will be applicable to them, so they will need to determine whether they are subject to an exemption, standard FSVP requirements, or modified FSVP requirements.”
On Oct. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Oct. 2 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Oct. 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration recently added “hundreds of products and companies” to its import alert on unapproved new drugs, consultancy Registrar Corp. said in a blog post. In an update to Import Alert 66-41 on Sept. 13, FDA blocked importation of a large number of products that are being marketed as a food, dietary supplement or cosmetic, but “made claims that qualified them as a drug,” Registrar said. “This is an abnormally high number of updates and additions for a single day,” it said. Products that claim to cure and mitigate disease are considered drugs by FDA and must be registered with FDA as such.