FDA plans for third-party certification, which serves as a key component of the Voluntary Qualified Importer Program, faces numerous challenges, the Government Accountability Office said in a report released Oct. 31. The report, “FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources,” recommended instead adapting FDA’s comparability assessment tool, currently in development, to determine whether exported food products are safe for domestic consumption. FDA disagreed with GAO’s conclusions.
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:
The Food and Drug Administration (FDA) threatened to place Polish fish processor Superfish S.A.’s marinated (pickled) and salted herring products on import alert for inadequate Seafood Hazard Analysis and Critical Control Points (HACCP) plans, it said in a warning letter dated Oct. 16. Various stages of Superfish’s production process do not include critical control points, critical limits, monitoring procedures, and corrective action plans, FDA said. FDA told the company to respond within 15 days or receipt of the warning letter with actions taken to correct the deficiencies. Superfish’s products may be subject to refusal of admission into the U.S. if Superfish fails to respond adequately, FDA said.
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. 26-28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 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 Oct. 24 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 sent a warning letter to medical device importer Primus Medical on Oct. 10, alleging an inadequate response to an inspection that revealed deviations from Current Good Manufacturing Practices (CGMP) regulations and failure or refusal to furnish information required by Medical Device Reporting regulations.
The Food and Drug Administration announced its fiscal year 2013 abbreviated new drug application (ANDA), prior approval supplement (PAS), drug master file (DMF), and backlog fees, pursuant to the Generic Drug User Fee Amendments (GDUFA) of 2012. The fees are effective Oct. 1, 2012, and will run until Sept. 30, 2013. Going forward, FDA will publish GDUFA fees 60 days prior to the beginning of each fiscal year, it said. GDUFA fees are expected to generate $299 million annually for FDA. The fees will be used to conduct activities such as increased inspections of foreign facilities.