Microbiology FDA 483 (Central Admixture Pharmacy): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented
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Firm / Company
Central Admixture Pharmacy Services Inc
System
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Specifically,
Your firm’s Quality Unit failed to perform a method transfer of your sterility test method used for release of drug products. Your firm utilizes the *** Microbial Detection System for sterility testing. The associated test method was developed and validated at the CAPS Technical Services Laboratory located in Irvine, CA. Your firm failed to conduct a method transfer ensuring the *** Microbial Detection System sterility method test method is suitable for release of your sterile drug products.
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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.