On July 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 17 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 July 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On July 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 15 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 to refuse imports of active pharmaceutical ingredients (APIs) made by a company in Italy because of violations of current good manufacturing practice (CGMP) requirements, in a warning letter dated July 7. FDA says employees of Trifarma’s facility in Rozzano, Italy deleted from its computers data on testing of APIs that were destined for the United States. That may have been because the facility allowed all of its laboratory employees full access to its computer systems, said FDA. The agency said this isn’t the first time this type of violation has cropped up at a Trifarma facility, noting similar issues it found at a different Trifarma plant in November 2013. FDA said failure to correct the violations may result in APIs from the Rozzano facility being placed on import alert.
On July 14 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 July 7-13, 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 July 10-11 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 July 9 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.