On June 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 adopting as final its interim regulations that established current good manufacturing practice (CGMP) requirements for infant formula. FDA is making some changes to the interim regulations, including provisions for an exemption from infant formula testing if the manufacturer or importer can show the new formula wouldn’t differ from a similar formula that’s already on the market. Manufacturers are required to comply with the new regulations by Sept. 8, 2014, except for some provisions which are getting a grace period until Nov. 12, 2015.
The Food and Drug Administration recently began increased sampling of imported and domestic whole pit avocados as part of an agency inquiry into salmonella and listeria contamination in guacamole, according to a notice dated May 23 that was posted by OHL and later confirmed by FDA to be authentic. The notice says sampling “is targeted to begin” in May 2014, and “will continue through” May 2015. FDA says “the majority” of the sampling will take place outside of the normal import clearance process, and it will release shipments for distribution by the importer before it gets the results of the sampling.
On June 5 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 threatened to refuse imports from a Sri Lanka seafood processor unless violations of multiple regulations are corrected. In a warning letter dated May 15, the agency told AMK Food Export (Pvt) Ltd. that an FDA inspection of its Homagama facility allegedly turned up violations of emergency permit control, thermally processed low-acid food, seafood hazard analysis and critical control point, and current good manufacturing practice regulations. Unless the violations are corrected, FDA says it may place any violative AMK products on import alert and refuse admission under detention without physical examination. FDA also told AMK that it may charge the company’s U.S. agent fees for costs the agency incurs during any reinspection.
On June 4 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 June 4 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 confirmed that an increase in its civil penalty amounts will take effect June 18. The agency first announced the inflation-related increase in February (see 14013113). FDA is at the same time allowing FDA staff other than the Office of Chief Counsel to authorize civil monetary penalty complaints against tobacco retailers.
On June 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: