The Food and Drug Administration issued its weekly Enforcement Report for Feb. 20 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Feb. 22 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 debarring Richard Stowell from importing food or offering food for importation into the U.S. in connection with his conviction for mislabeling shrimp imports. Stowell, who was president of Florida-based seafood wholesaler United Seafood Imports, pleaded guilty in 2011 to one count of conspiracy to falsely label and misbrand seafood, one count of false labeling of seafood under the Lacey Act, and one count of misbranding food.
On Feb. 21 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 a guidance is now available on industry implementation of Physician Labeling Rule content and format requirements in labeling for human drug and biological products. FDA said the guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the physician labeling requirements. The Physician Labeling Rule, published in 2006, addresses prescription drug labeling that is used by prescribers and other health care practitioners. Comments on the guidance may be submitted at any time, FDA said. The guidance is available here.
On Feb. 20 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 Feb. 11-17, 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 sent a warning letter to Belgian device manufacturer Medsys, alleging several violations of FDA regulations including Medical Device Reporting. FDA said it will deny premarket approval applications for Class III devices related to the violations, and will not grant requests for certificates to foreign governments, until the violations have been corrected.
The Food and Drug Administration said a draft guidance on distinguishing device recalls from product enhancements is now available. The guidance would clarify when a change to a device meets the definition of a recall, and whether FDA should be notified. Device improvements do not necessarily mean old versions of a device need to be recalled, FDA said, but when the new version of a device corrects an identified defect or failure the public should be notified without delay. Comments on the draft guidance are due by May 23.
On Feb. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: