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The FDA cited six devicemakers for numerous violations including issues with CAPAs, training, MDRs, complaint handling, improper calibration and validation procedures. Read More
The FDA cited Arcamed for deficiencies in its CAPA procedures and issues with its quality audit and employee training procedures after a February/March inspection of the company’s Indianapolis facility. Read More
The FDA slapped Gendron with a Form 483 for shoddy complaint handling and deficient MDR procedures, as well as issues with its internal quality auditing. Read More