The Food and Drug Administration issued its weekly Enforcement Report for June 18 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 17 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 announced the reclassification of blade-form endosseous dental implants as Class II medical devices subject to special controls. The dental implants were previously classified in Class III and required premarket approval. The reclassification will take effect July 18; Although the devices will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling..
The Food and Drug Administration threatened Chinese and India drug makers with import refusal in two recent warning letters. In a letter dated June 10 (here), FDA told Tianjin Zhongan Pharmaceutical of China that it needs to correct violations of current good manufacturing practice (CGMP) requirements or else face an import alert on its active pharmaceutical ingredients (APIs). In a separate letter dated June 16 (here), FDA told Apotex Pharmachem India that it will continue to refuse imports of APIs from the company, also for violations of CGMP requirements.
The Food and Drug Administration may refuse imports of pharmaceuticals from a Spanish company for failure to pay generic drug user fees, it said in a warning letter dated June 2. According to FDA, Leon-based generic drug manufacturer Antibioticos did pay fees required by the Generic Drug User Fee Amendments of 2012 (GDUFA) for fiscal years 2013 and 2014. As a result, FDA has put Antibioticos on its GDUFA Arrears List (here), and says it may put the company on import alert and refuse imports of generic drugs exported by Antibioticos.
On June 16 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 June 9-15, 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 more time for comments on the implementation of new reporting requirements under the Food Safety Modernization Act. Under FSMA, human and animal food facilities that are required to register with FDA must submit consumer-oriented information for use in the agency’s Reportable Food Registry. FDA in March asked for comments on the information that should be provided and how that information should be passed onto consumers (see 14032516). It is now extending the period for submitting comments until Aug. 18.
On June 13 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 classifying nonabsorbable expandable hemostatic sponges for temporary internal use as Class II devices that do not require premarket approval, in an order that codifies a classification that took effect April 3. 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 RevMedx related to its XSTAT device. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing, biocompatibility and labeling. They will not be exempt from premarket notification requirements.