Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
She described her cousin's basement, garage and dorm as being an epicenter for drug use, where he would also put baby ...
The US Food and Drug Administration hit two foreign seafood processors and one Buffalo, New York-based seafood importer with warning letters this week ...
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells. According to the ...
Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...
It followed up with a first block of 10 warning letters – aimed at manufacturers of asthma inhalers, epinephrine autoinjectors, and other drug products – challenging around 100 patents a few ...