Microbiology FDA 483 (Sentara Enterprises): Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air
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Sentara Enterprises
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Specifically, on July 11, 2023, while Technician *** was observed working in ISO 5 classified *** laminar airflow hood s, (equipment ID ***) , producing SODIUM CHLORIDE 0.9% 2000ML Rx *** was observed introducing sterile IPA bottle into ISO 5 classified *** laminar airflow hood without sanitizing the outer surface.
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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.