On Feb. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 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 issued its weekly Enforcement Report for Feb. 26 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 “has been closely monitoring the supply chain with the expectation that the COVID-19 [coronavirus] outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said in a news release. The agency has communicated with more than 180 drug manufacturers to remind them about notification requirements for supply disruptions, it said. “Also, as part of our efforts, the FDA has identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China,” it said. “We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs.”
On Feb. 26 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 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. The comments are due April 6.
On Feb. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Imports do not pose a higher public health risk as a result of the ongoing COVID-19 (coronavirus) outbreak, the Food and Drug Administration said in a Feb. 24 statement. “There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods,” FDA said, though it noted that “this remains a dynamic situation and we will continue to assess, and update guidance as needed.”
On Feb. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: