The Food and Drug Administration issued its weekly Enforcement Report for Jan. 7 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On Jan. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
A New York-based seafood importer faces a ban on its imports of fish and fishery products, said the Food and Drug Administration in a warning letter dated Dec. 8 (here). The agency said an inspection of Yandi New York Trading Co. Ltd.’s Brooklyn, New York facility turned up violations of seafood hazard analysis and critical control point (HACCP) regulations in the company’s imported dried anchovies. If the violations aren’t corrected, FDA says it will place the company’s seafood imports on detention without physical examination. FDA also said it may assess fees for the cost of any reinspection to verify the importer has brought itself into compliance.
The Food and Drug Administration may refuse imports of pharmaceuticals manufactured at a Chinese facility because of violations of current good manufacturing practice requirements, it said in a warning letter dated Dec. 19 (here). The agency said its inspectors found the violations in manufacturing procedures for finished pharmaceuticals and active pharmaceutical ingredients during a tour of Novacyl Wuxi Pharmaceutical Co., Ltd.’s facility in Wuxi, China. Unless they are corrected, FDA may place products from the facility on import alert and detention without physical examination, it said.
On Jan. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Pharmaceutical manufacturers, distributors and repackagers will be given a four-month grace period before having to comply with product tracing requirements under the Drug Supply Chain Security Act (DSCSA), said the Food and Drug Administration in a guidance document issued Dec. 24 (here). Under DSCSA, “trading partners” are required to provide the next purchaser in the supply chain with product tracing information when engaging in transactions involving prescription drugs, and must maintain the information for at least six years after the relevant transaction. The product tracing requirements were set to take effect on Jan. 1, but in response to concern that “unforeseen complications” could disrupt the supply chain and impact patients’ access to needed prescription drugs, FDA will give manufacturers, wholesale distributors, and repackagers until May 1, 2015 before taking action against trading partners who are not in compliance, it said.
On Dec. 24 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. 15-21, 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: