Microbiology FDA 483 : Smoke studies were inadequately performed under dynamic conditions
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Surgery Pharmacy Services Inc
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Smoke studies were inadequately performed under dynamic conditions. Specifically, your videos of the smoke studies conducted on Month ***, 2023 do not show manipulations or conditions performed hat would be _ representative of the dynamic process used in actual compounding processes using the *** ****. For example, the *** additions of volumes deemed too small to be added to the final products; the connection of the TPN bag to the tubing, the powered on state of the *** and scale; and connections made to all *** component stations are not performed during the smoke study.
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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.