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:
On Nov. 26 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 asking for comments by Jan. 27 on its collection of information from import entry documentation. In addition to reviewing information provided to CBP through the Automated Commercial System, FDA also requires importers to declare the FDA Product Code, FDA country of production, manufacturer/shipper, and ultimate consignee, before the agency makes its admissibility decision. FDA says 3,406 respondents report that information each year for non-tobacco shipments, providing 1,089 responses each that take 8 minutes each to compile, for a total of 517,219 burden hours each year.
The Food and Drug Administration is finalizing amendments to its food additive regulations to implement food-grade specifications from the 7th Edition of the Food Chemical Codex. The final rule makes changes regulations on 32 food additives, taking effect on Nov. 29. Objections and requests for hearings are due by Dec. 30.