JD Supra2d
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 ...
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 ...
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 ...
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 ...
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 ...
ENDPOINTS NEWS12d
FDA sends warn­ing let­ter to In­di­an drug­mak­er af­ter find­ing glass in in­jec­tions
Indian generic manufacturer Zydus Lifesciences was hit with an FDA warning letter on Tuesday after it shipped vitamin B ...
medtechdive10d
FDA warns 2 Chinese labs for oversight failures, animal care violations
The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.
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.
Business Insider9d
Outset Medical (OM) Shares Down 94% Since Disclosing FDA Warning Letter, Class Action Pending - Hagens Berman
The situation began to unravel on July 7, 2023, when Outset Medical announced it had received a warning letter from the FDA. The letter asserted that the company was promoting a Tablo product ...
Law Street Media3d
High-Flying iRhythm Faces Scrutiny
iRhythm’s stock price has been volatile over the past five years, climbing as high as $274.21 and declining as low as $41.66. It was down 30 percent for 2024 and stood at $86.25 the day before the ...