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 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 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.
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.
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:
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:
During the week of May 26 - June 1, 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 is formally reclassifying powered surgical instrument for improvement in the appearance of cellulite as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect July 12, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA is reclassifying them in response to a request from Cabochon Aesthetics related to the Cabochon System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.
On May 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: