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Documentation, Procedural Shortfalls Spur Form 483 for Fresenius

Dialysis-drug maker Fresenius has been handed a Form 483 after an FDA inspection of its Ogden, Utah, facility raised concerns that post-sterilization visual inspections performed on solution bags may not be effective at catching leaks or contaminants. Citing product complaints about leaks and “particulates” located on or outside terminally sterilized drug bags, investigators noted there is no procedure at the plant for training inspection personnel for particulate inspection.
Drug GMP Report