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:
On March 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 11 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 11 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 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 9 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 suspending foreign inspections through April, effective immediately, in response to the coronavirus outbreak, FDA said in a March 10 statement. “Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis,” it said. The decision comes as a result of recommendations from other agencies, including the State Department’s prohibition on travel by U.S. government employees. “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government,” FDA said. In the meantime, FDA will rely on other means to prevent entry of unsafe products, including records requests, examinations and product sampling at the border, it said.
On March 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: