On May 3-5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 1 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 said it will refuse imports of MEDICAMAT S.A.’s “Punch-Hair-Matic-Suction Assisted Follicular Extraction and Re-implantation” device, after discovering that the device is intended for unregistered uses and is not covered by a premarket approval or investigational device exemption for those uses.
The Food and Drug Administration issued its weekly Enforcement Report for April 24 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
A revised guide is now available on controls for safe and sanitary growing, harvesting, processing, and shipping of oysters, clams, mussels, and scallops for human consumption, the Food and Drug Administration said. The changes were adopted at the 2011 biennial meeting of the Interstate Shellfish Sanitation Conference, and then went through an FDA concurrence process. As such, the guide “represents the agency’s current thinking on appropriate controls,” FDA said.
On April 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 29 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 April 22-28, 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 issued an order debarring Ashley Brandon Foyle for five years from providing services to any person that has an approved or pending drug product application, in connection with his 2010 conviction for introducing and delivering into commerce a misbranded drug. Foyle had imported omeprazole from Muhi Trading Corporation, and his company Omega Biotech had repackaged and sold the drug. Neither Foyle, Omega, or Muhi Trading were registered to manufacture, prepare, propagate, compound, or process drugs, FDA said.