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 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.
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 threatened to refuse imports of pharmaceuticals manufactured at two Indian facilities owned by Wockhardt Limited, in the second warning letter sent to the company in under five months. FDA’s second letter, dated Nov. 25, once again detailed violations of current good manufacturing practice requirements at Wockhardt facilities located in Chikalthana and Waluj, Maharashtra.
On Dec. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: