Intermittent issues on Aug. 27 related with the Food and Drug Administration's application for manually reviewing entries may lead to delays beyond routine time frames in processing entries, CBP said. According to CBP, these issues are being investigated and district personnel have experienced higher caller volume as a result.
On Aug. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 26 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 Aug. 20-26, 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:
The Food and Drug Administration asked for notification of all imports of laser products so the agency can review admissibility, in an Aug. 12 letter to CBP. That includes informal and Section 321 low value entries, FDA said. The request for CBP notification is in response to mail and courier shipments of laser pointers that have been misdeclared as toys and flashlights to circumvent review, FDA said. The food, drug and device regulator needs to check if the laser pointers meet maximum energy output standards, it said.
On Aug. 23-25 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 threatened two Indian drug companies with refusal of their products at the border for violations of current good manufacturing practice requirements. FDA told Posh Chemicals in a warning letter Aug. 2 that active pharmaceutical ingredients (APIs) from its facility in Hyderabad may face import alert and detention without physical examination unless CGMP violations are corrected (here). And in a warning letter sent Aug. 9, FDA told Sentiss Pharma (formerly Promed Exports) that it will continue to refuse finished pharmaceuticals already subject to DWPE from the company’s Khera Nihla Village facility for uncorrected CGMP violations (here).
On Aug. 22 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 warned two foreign food companies that it may refuse admission to some of their products after finding violations of FDA regulations. The agency sent warning letters to Grant's Smokehouse of the United Kingdom on July 8 (here), and Waterwheel Premium Foods of Australia on July 26 (formerly Philemon) (here). Because Grant’s violations were “materially related to food safety,” FDA said it’s going to charge the company’s U.S. agent for any required reinspection.
On Aug. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: