Microbiology FDA 483 (Empower Clinic Services) : Failure to clean and disinfect or sterilize equipment located in the ISO 5 area
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Empower Clinic Services LCC dba Empower Pharmacy
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Specifically, your firm’s *** management reported it has no data to ensure clean/deactivation reagents and methods used within the ISO 5 Cleanroom for the *** filling/ stoppering/ capping equipment is adequate to present cross contamination of hazardous and on-hazardous sterile finished drug products. Your firm’s quality manager reported all sterile drug products undergo sterility, endotoxin, and potency testing only. No other laboratory testing is performed to ensure cleaning effectiveness and deactivation of hazardous APIs and or excipients in the prevention of cross contamination.
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FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.