Microbiology FDA 483 (Aurobindo/Eugia Pharma) : No appropriate controls for computers or related systems
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Eugia Pharma Specialities Limited
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There are no controls to prevent operators from changing the date and time on the Climet non-viable particle count equipment. Operators stated they had changed the date and time to back date printouts. Additionally, the instrument is capable of storing and backing-up electronic data, but the function is not used.
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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.