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.
On March 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 18 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 March 18 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 17 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 is temporarily loosening on-site supplier audit requirements for importers under the agency’s preventive controls and Foreign Supplier Verification Program regulations, it said in a new guidance document. Under both sets of regulations, importers may conduct audits of supplier verification activities, and on-site audits are the preferred verification activity when the supplier controls a hazard that risks serious health consequences or death. But FDA says that travel advisories and restrictions resulting from the COVID-19 pandemic may impact the ability of receiving facilities and FSVP importers to conduct or obtain on-site audits of their suppliers. As a result, FDA will, for the time being, not enforce on-site audit requirements in countries where travel advisories or restrictions due to COVID-19 make it impossible to conduct the on-site audit, as long as an alternative verification activity is selected. The guidance takes effect immediately.
On March 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: