The Food and Drug Administration issued a new import alert Sept. 16 to block imports of drug products manufactured at Ranbaxy Laboratories’ facility in Mohali, India. FDA also extended the terms of a 2012 settlement that covered other Ranbaxy facilities in India to also cover the Mohali facility.
The Food and Drug Administration spelled out the rationale and expected processes for the proposed systems recognition assessment program, meant to help the FDA identify countries with effective food safety systems. FDA has been testing and developing a process for conducting systems recognition assessments, "working with New Zealand and the European Union (EU) on initial pilot projects and Canada on a second pilot project," it said. "FDA expects that systems recognition assessments will be a key tool for FDA to utilize in its preventive approach to food safety for imported foods," it said.
The Food and Drug Administration will be deleting some of the product codes for the Center for Devices and Radiological Health, effective Sept. 30, CBP said. CBP said that use of these after that date will lead to a data transmission error. See the full list of deleted codes (here).
The Food and Drug Administration issued its weekly Enforcement Report for Sept. 4 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Sept. 4 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 intends to use DUNS numbers assigned by Dun and Bradstreet as Unique Facility Identifiers for domestic and foreign drug facility registration required by the Food and Drug Administration Safety and Innovation Act (FDASIA), it said in a draft guidance (here) posted Sept. 4. DUNS numbers (here) are free and are already widely used for drug registration, and meet agency needs, FDA said. The draft guidance only applies to registration requirements found in Sections 701 and 702 of FDASIA, and not to registration requirements for excipient manufacturers in Section 703 of the law. Comments on the draft guidance are due by Nov. 5
On Aug. 30 - Sept. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 28 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 Aug. 28 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.