Microbiology FDA 483 (Central Admixture Pharmacy): Not include the establishment of scientifically sound and appropriate specifications
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Central Admixture Pharmacy Services Inc
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Your firm failed to provide scientific evidence that endotoxin specification for products intended for epidural administration is adequate. Specifically,
The endotoxin limits required by your firm for the IV and epidural products are the same, for example, NMT ***EU/mg of Fentanyl and NMT ***EU/mg of Bupivacaine. However, according to USP Chapter <85> the endotoxin limit for intrathecal products is 0.2 EU/kg, and the limit for parenteral products is 5 EU/kg. The endotoxin limit that is applied for intrathecal products should also be applied for epidural products. Some examples of your product release specifications for both epidural and IV products are listed below. This is not an exhaustive list.
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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.