The Food and Drug Administration issued its weekly Enforcement Report for June 26 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On June 25 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 June 17-23, the Food and Drug Administration modified the following existing Import Alert (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On June 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Exporters of active pharmaceutical ingredients to the EU will avoid burdensome certification requirements, after the European Commission declared the U.S. a “listed” country June 21 (here). Without the waiver, all U.S. companies shipping APIs to Europe after July 1 would have had to first submit documentation from the Food and Drug Administration that the product was manufactured in accordance with Europe’s good manufacturing practices, FDA said.
The Food and Drug Administration is proposing amendments to its performance standard for laser products. FDA said the changes would harmonize its requirements with the International Electrotechnical Commission’s standards for laser products and medical laser products. It would also “reduce the economic burden on affected manufacturers,” and better protect public health, FDA said. Any final rule implementing the changes would not be effective until at least two years after publication, FDA said. Comments on FDA’s proposal are due by Sept. 23.
The Food and Drug Administration issued its weekly Enforcement Report for June 19 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 revised a list of ports of entry that will participate in the centralized entry review pilot (see 13061915), said CBP in a CSMS message. The revised list of port numbers are: 2095, 2791, 2792, 2795, 2870, 2895, 3195, 3196, 4670, 4671, 5295, 5296, 5297, and 5298.