On Dec. 12 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 Dec. 11 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 issued the Interstate Certified Shellfish Shippers List (ICSSL) for December. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Dec. 11 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 Dec. 2-8, 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:
On Dec. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 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 will refuse imports of medical devices from Indian device manufacturer Shoney Scientific until misbranding and current good manufacturing practice violations are corrected, said the agency in a warning letter dated Nov. 20. FDA said an inspection of Shoney’s Pondicherry facility revealed departures from CGMP including a failure to establish manufacturing equipment monitoring and calibration procedures. The letter also said one product manufactured at the facility, the “Disposable Biopsy Punch,” is misbranded because it is being marketed for an unapproved use. FDA exempts biopsy punches from premarket notification requirements as long as they are for general dentistry and oral surgery procedures, but Shoney’s website says that the device can also be used for “correcting vitiligo,” because “the smaller sizes of the biopsy punch are also used for hair transplant.”
The Food and Drug Administration issued its weekly Enforcement Report for Dec. 4 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.