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Diabetes Care (2010) 33(2):42833.10.2337/dc09-1499 65 EganAGBlindEDunderKde GraeffPAHummerBTBourcierTet alPancreatic safety of incretin-based drugs FDA and EMA assessment
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Specific findings from FDA inspections include failure to monitor cleanroom environments where sterile drugs are prepared, inadequate sterilization of equipment used in drug production, release of a batch of vitamin B6 despite microbial contamination detected in the production room, incomplete cleaning validation for equipment used in compounding implantable pellets, and repeat violations that were identified in previous inspections but not corrected
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