Microbiology FDA 483 (Wedgewood Connect): Aseptic areas are deficient for cleaning and disinfecting the room and equipment to produce aseptic conditions
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Wedgewood Connect, LLC
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Specifically, disinfectant efficacy studies have not been performed for the ***, and the *** cleaning solutions used within your IS0-5 and ISO-7 aseptic processing areas, to confirm these solutions are appropriate for use within these areas and against all surface types they are used on. The IS0-5 and IS0-7 aseptic processing areas are used for human and animal drug production.
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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.