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The FDA cited three devicemakers for nonconforming products, documentation failures, inadequate CAPAs and numerous other problems found during agency inspections. Read More
Abaxis was hit with an FDA warning letter over changes it made to a potassium assay used with its chemistry analyzer device that caused the product to be adulterated and misbranded. Read More
The FDA issued a warning letter to TEI Biosciences’ for “systemic” quality failures the agency found during an Oct. 9 to Nov. 2, 2018, inspection of its Boston, Mass., facility. Read More
LC Medical Concepts’ sterilization operations were not adequately validated to demonstrate sterility of its wound therapy kits, an Oct. 16-23, 2018, FDA inspection of the devicemaker’s Rochester, New York, facility revealed. Read More