During the week of July 28 - Aug. 3, 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 Aug. 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 issued its weekly Enforcement Report for July 30 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 intends to exempt a lengthy list of Class II and “reserved” Class I medical devices from premarket notification requirements, it said in a draft guidance issued Aug. 1 (here). The agency says the devices “are sufficiently well understood and do not present risks that require premarket notification” under Section 510(k). FDA says it will eventually issue an order in the Federal Register exempting the devices. But in the meantime, FDA says it will not enforce premarket notification requirements for the devices. Comments on the draft guidance are due Sept. 30, said FDA in a concurrent Federal Register notice (here).
On July 30 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 set potential fiscal year 2015 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees. The agency set FY 2015 fees of $217/hour for domestic services and $305/hour if foreign travel is required. Last year, the agency set FY 2014 at $237/hour and $302/hour, respectively. The fees are effective Oct. 1.
On July 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 28 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 21-27, 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:
The Food and Drug Administration may continue to refuse imports of active pharmaceutical ingredients from a Chinese drug conglomerate after an inspection by agency officials detailed violations of current good manufacturing practice requirements, it said in a warning letter dated July 9. FDA said until the violation are corrected, it may keep APIs made by Zhejiang Jiuzhou Pharmaceutical or exported by its trading company Zhejiang Zonebanner Jiuzhou Imp. & Exp. on import alert.