The Food and Drug Administration issued its weekly Enforcement Report for April 1 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.
The Food and Drug Administration is again extending the comment period on its proposal (see 1911060035) for a new accreditation scheme for food testing laboratories that would require importers to use accredited laboratories in some circumstances, including getting food they import off import alerts and proving admissibility of food that is initially refused admission. FDA says the extension is “in response to a request from several food industry associations to extend open comment periods while their members focus on continuity of critical infrastructure operations due to the recent COVID-19 public health declaration.” Comments are now due July 6.
On April 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 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 released a pair of guidance documents detailing its enforcement policies for gowns, other apparel and gloves, and sterilizers, disinfectant devices and air purifiers, during the COVID-19 public health emergency. The guidance documents include information on how different types of these products are regulated by FDA, as well as temporary enforcement discretion policies for some of these products that temporarily liberalize FDA’s rules.
The Food and Drug Administration issued its weekly Enforcement Report for March 25 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 March 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Importers of some N95 respirators and COVID-19 diagnostic tests that have been authorized pursuant to a Food and Drug Administration Emergency Use Authorization (EUA) must still submit a reduced entry dataset to FDA, CBP said in a recent CSMS message. For product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies), as well as product codes QPK, OTG, QKO, and QJR (various forms of diagnostic tests for COVID-19), importers must transmit an intended use code of 940.000 (Compassionate Use/Emergency Use) and an appropriate FDA product code, CBP said.