The Food and Drug Administration issued its weekly Enforcement Report for Aug. 7 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 is once again extending the period for comments on its preventative controls (here) and produce safety (here) rules, this time until Nov. 15. The 60-day extension will allow for consideration of the food safety standards in the context of the Foreign Supplier Verification Program (FSVP) and third-party auditor accreditation proposals, published July 29 (see 13072623). “This is the second and final extension of the comment period for these two rules,” FDA said. The agency had already allotted more time for comments in April (see 13042421).
The Zip International Group of Edison, N.J., is recalling Baltic sprats in spicy brine because it could potentially be contaminated with the organism Listeria monocytogenes, the Food and Drug Administration (FDA) announced on Aug. 5. The Baltic sprats, originating from Latvia, were sold to distributors and retail grocery stores in the state of N.Y. from May 31 to June 6. The product is in plastic packaging that includes a best by date of Oct. 12. The recall was initiated following a routine sampling by the New York Department of Agriculture & Markets Food Inspectors, where subsequent analysis “found the product to be positive for Listeria monocytogenes."
On Aug. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 6 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The Food and Drug Administration is withdrawing 23 out-of-date draft guidances, as part of a clean-up of its draft guidance documents issued before 2010. The draft guidances being withdrawn cover topics like drug development and approval, current good manufacturing practice (CGMP) requirements for drugs and labeling in abbreviated new drug applications (ANDAs). According to FDA’s Center for Drug Evaluation and Research, FDA has in most cases developed other guidances to replace the withdrawn documents.
On Aug. 5 the Food and Drug Administration posted a new and revised version of the following Import Alerts on the detention without physical examination of:
During the week of July 30 - Aug. 5, 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. 2-4 the Food and Drug Administration posted a new and revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for July 31 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.