The Food and Drug Administration issued its weekly Enforcement Report for Dec. 19 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Dec. 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 threatened device importer and distributor Prime Herbs Corp. with seizure, injunction, and civil monetary penalties for a host of violations that caused FDA to declare the company’s infrared heating lamp adulterated and misbranded. The warning letter, dated Dec. 10, alleges violations of current good manufacturing practice regulations, Medical Device Reporting violations, unapproved marketing, and failure to provide adequate directions for use. FDA said the violations could also affect the awarding of government contracts, as well as premarket approval for related products.
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:
During the week of Dec. 10-16, 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. 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.