As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The U.S. Food and Drug Administration has issued warning letters to four companies — Zest US Wholesale Inc., Xin Ao International Group Corp., Gongora USA Corp., and San Juan Produce LLC — for ...

Q’Apel recalled the device in February, three weeks after the FDA sent the warning letter. The company asked customers to quarantine and return all affected systems in exchange for credit.

Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat, which was rejected by the agency last week. The letter – addressed ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

Thom Tillis went to the Senate floor and slammed the GOP’s plans for drastic Medicaid cuts — warning Republicans they are about ... and experts from the nascent straight-to-consumer drug industry are ...

The FDA was particularly concerned about the selling of unapproved CBD products for food-producing animals. The FDA's Center ...

In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back ...

Unicycive Therapeutics has hit a bump on the road in its mission to bring its hyperphosphatemia treatment candidate to ...

Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...