The Food and Drug Administration issued its weekly Enforcement Report for July 8 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On July 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 6 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 on July 7 issued an order debarring Chung Po Liu from importing food for a period of five years due to his conviction for honey smuggling (here). According to FDA, Liu pleaded guilty in 2010 to misrepresenting the country of origin of honey he imported from China so as to avoid paying antidumping duties. Liu also admitted that he had introduced honey that contained the unsafe food additive ciprofloxacin, an antibiotic, said FDA.
On July 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 1 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 on July 2 announced its intent to step up enforcement on unapproved ear drops labeled for treatment of ear infections and inflammation (here). The agency says unapproved and misbranded single-ingredient otic drug products containing benzocaine; fixed-dose combination otic drug products containing benzocaine and antipyrine; fixed-dose combination otic drug products containing benzocaine, antipyrine, and zinc acetate; fixed-dose combination otic drug products containing benzocaine, chloroxylenol, and hydrocortisone; fixed-dose combination otic drug products containing chloroxylenol and fixed-dose combination otic drug products containing chloroxylenol, pramoxine, and hydrocortisone are being marketed without evidence of safety or effectiveness, and have resulted in several cases of allergic reactions. FDA “intends to take enforcement action against such products and those who manufacture them or cause them to be manufactured or shipped in interstate commerce,” it said.
On June 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: