During the week of July 23-29, 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 of:
On July 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 25 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 is asking for comments on possible changes to its regulation requiring animal drug sponsors to submit reports, including periodic drug experience reports containing drug distribution data showing the amount of the drug distributed domestically and the amount exported. Specifically, FDA is seeking comments on: (1) whether it should require the submission of additional sales and distribution information including an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each approved food-producing animal species; (2) how to compile and present its annual summary report of the sales and distribution data collected from sponsors of antimicrobial new animal drugs; and (3) alternative methods available to FDA for obtaining additional data and information about the extent of antimicrobial drug use in food producing animals. Comments are due by Sept. 25.
On July 24 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 25 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 posted warning letters that it has sent to companies from Taiwan, Indonesia, and France, threatening detention without physical examination and/or suspension and revocation of licenses. Indonesian device manufacturer Gooten Innolife Corp. (here) was told that some of its products will remain on detention without physical examination until violations of current good manufacturing practices (CGMPs) are corrected, and French drug manufacturer Sanofi Pasteur (here) and (here) was threatened with license suspension and/or revocation for the same reason. The FDA told Indonesian fish processor P.T. Super Saku Bali (here) that its products may be refused entry through detention without physical determination if it doesn’t submit a revised Hazard Analysis and Critical Control Point (HACCP) plan.
On July 23 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 16-22, 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 of: