The Food and Drug Administration said it may refuse imports from pharmaceutical manufacturers in India and Germany, in separate warning letters sent to the companies in April and May. FDA said an inspection of a Sun Pharmaceutical Industries manufacturing facility in Gujarat, India turned up violations of CGMP requirements for both finished pharmaceuticals and active pharmaceutical ingredients (APIs) (here). It also told SANUM-Kehlbeck that an inspection of the pharmaceutical manufacturer’s facility in Hoya, Germany found violations of CGMP requirements for both finished pharmaceuticals and APIs, as well as a failure by the company to register with FDA (here). The agency told both companies that their drug products are subject to refusal of admission because of the violations.

The Food and Drug Administration told a fish importer that it may begin refusing admission to its products because of violations of hazard analysis and critical control point (HACCP) and acidified food regulations. In a warning letter dated May 13, FDA said Ridgewood, New York-based Maharaja Foods Importers failed to take steps to ensure its shelf stable glass-packed pickled tuna in oil complies with HACCP requirements. The agency also said that an inspection of an entry of Maharaja’s pickled tuna revealed that the foreign exporter didn’t register as an acidified food manufacturer. FDA said that, unless corrected, it may begin refusing shipments imported by Maharaja at the border. It also said it may collect fees to cover the costs of reinspection.

The Food and Drug Administration is extending until July 30 the period for comments on its proposed rule on the sanitary transportation of human and animal food. The proposed regulations issued under the Food Safety Modernization Act in February would apply to shippers, receivers, and carriers that transport human or animal food by truck or rail, including parties engaged in the international shipment of food in some circumstances (see 14020301). If an international shipper or carrier is subject to the rule and fails to comply, the food shipment would be refused entry into the U.S., said FDA in its proposed rule. FDA is extending the deadline because of requests from industry. Under a court settlement, FDA’s final rule on sanitary transportation is due March 31, 2016.

On May 20 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 proposing to reclassify rapid influenza detection test systems from class I to class II. The reclassification would apply to antigen-based rapid influenza virus antigen detection test systems used to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents. It would make the test systems subject to premarket notification, and would designate special controls the agency deemed necessary for safe use. FDA would also change the name of the products to "influenza virus antigen detection test systems.” Comments on the reclassification are due by Aug. 7.

On May 19 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 May 12-18, 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:

The Food and Drug Administration will allow use of the high-intensity sweetener advantame as a food additive, except in meat and poultry, it said in a final rule that takes effect May 21. The free-flowing, water soluble, white crystalline powder can now be used as a general-purpose sweetener and flavor enhancer in baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings and syrups, it said. FDA says it evaluated a variety of animal and human studies, and found the additive to be safe. Advantame is the sixth high-intensity sweetener approved by FDA, it said in a concurrent constituent update (here). Objections and requests for a hearing on the final rule are due June 20.

On May 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: