On Nov. 3 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 finalized its guidance that outlines the Unique Facility Identifier (UFI) system for use in registration foreign and domestic drug facilities (here). The guidance specifies that drug establishments should include a Data Universal Numbering System (DUNS) from Dun and Broadstreet as the UFI in their initial registrations and annual registration renewals, although other forms of identifiers are allowed with FDA approval. The final guidance makes few changes from a draft guidance issued in September 2013 (see 13090518). DUNS numbers are already required for drug establishments to register in the electronic Structured Product Labeling format, said an FDA spokesman.
During the week of Oct. 27 - Nov. 2, 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 Nov. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 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 issued its weekly Enforcement Report for Oct. 29 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 Oct. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: