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CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Cross contamination with other products
Undeclared Allergen - Soy
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Mustard potato salad is being recalled due to plastic foreign material.
Firm made non-alcoholic drink mixer in an unlicensed and uninspected facility. The product safety is concerned due to potential under-processing.
During an inspection by the SCDA the firm was notified that their label does not declare the allergen wheat.