On Dec. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 12 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 Dec. 12 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration and New Zealand signed an agreement recognizing that the U.S. and New Zealand food safety systems are comparable. The arrangement is the first time FDA has recognized another country’s food safety system as comparable. “Systems recognition,” as the FDA now terms it, previously referred to as comparability, involves reviewing a foreign country’s food safety regulatory system to determine if it provides a similar set of protections to that of FDA. Outcomes of these reviews may be used by FDA to make risk-based decisions regarding foreign inspections, admitting product into the U.S., and follow-up actions when food safety incidents occur, FDA said.
On Dec. 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 sent a warning letter dated Nov. 19 to MedArt A/S, a Danish medical device manufacturer, detailing violations of medical device reporting regulations and current good manufacturing practices. FDA ordered the firm to respond within 15 business days of receipt. The warning letter did not specify any consequences for failure to comply.
During the week of Dec. 3-9, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Dec. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: