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The FDA faulted the Siemens facility for not properly verifying the accuracy of the reagent expiration dates its software calculated and generated. Read More
The FDA handed a warning letter to Anigan for numerous GMP violations it uncovered during an April 2018 inspection of the firm’s San Ramon, California facility. Read More
The FDA found design verification and quality audit deviations in a February/March inspection OptumHealth Care Solutions facility in Rye Brook, New York. Read More
Siemens Healthcare Diagnostics fell short on CAPA procedures, acceptance activities and equipment maintenance, the FDA said in a Form 483 issued the form after a February/March inspection of the devicemaker’s East Walpole, Massachusetts, facility. Read More
The FDA cited Advanced Monitored Caregiving after a March inspection of the devicemaker’s New York facility turned up problems with procedures for device acceptance and evaluation of potential suppliers. Read More
The FDA hit six U.S. devicemakers with 483s for problems agency investigators observed in facility inspections including inadequate risk procedures, labeling and complaint handling. Read More