Maggots, other violations reported at North Carolina drug factory
A drug production facility in Durham run by a Chinese company violated multiple safety regulations, according to the FDA. A ...
US FDA sends warning letters to two Chinese firms for violating lab practices
The U.S. Food and Drug Administration issued warning letters to two Chinese third-party testing firms on Wednesday, citing ...
FiercePharma11d
India's Zydus hit with warning letter as FDA flags glass contamination concerns and more
Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking ...
MedPage Today4d
Eye Drop Company in FDA's Sights Once Again
In its latest warning letter, FDA raised concern that the company was still producing eye drops with amniotic fluid, even ...
JD Supra4d
FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests
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 ...
JD Supra3d
Test Anxiety: FDA Issues Warning Letters to Test Laboratories
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.
Food Safety News6d
FDA warns food companies for violations in acidified foods and seafood imports
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
Homeopathic company refuses to recall life-threatening nasal spray, FDA says
The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and ...
Plastics Today10d
FDA Issues Warning Letters to Chinese Testing Labs
The firms, which provide third-party testing and validation data services to medical device manufacturers, were found to have “pervasive failures” that could lead to faulty data.
Food Safety News13d
FDA issues warnings to water company over mold contamination and infant formula producer lacking Cronobacter testing
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...