From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing ...
FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of important documents from a facility ...
U.S. health inspectors are still struggling to address a massive backlog of pharmaceutical plants that went uninspected ...
In its latest warning letter, FDA raised concern that the company was still producing eye drops with amniotic fluid, even ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
The FDA has issued a warning letter to Regenerative Processing Plant after conducting an inspection of the facility. The plant manufactures two ophthalmic drug products, Regener-Eyes Professional ...
Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ...
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in ...
The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...
A drug production facility in Durham run by a Chinese company violated multiple safety regulations, according to the FDA. A ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
Incidents related to drug use inside a low-security women's prison in Waseca prompted officials to initiate ...