Microbiology FDA 483 (Zydus Lifesciences): Procedures to prevent microbiological contamination are not followed
Observation
Facility Type
Firm / Company
Zydus Lifesciences Ltd.
System
Details
Procedure 0317-SOP-MFG-00039 “Clean room and aseptic behavior” was not followed to ensure sterilized components are only contacted with sterile forceps and aseptic manipulations are performed from the side, so as not to disrupt the laminar air flow. For example:
(1) During an investigation to adjust the stopper bowl alignment during aseptic filling of *** of batch *** (US market batch), the operator allowed the *** RABS *** to contact sterile stoppers. These stoppers were subsequently returned to the stopper bowl.
(2) During observation of aseptic filling activities for *** batch *** (US market batch), media fill *** and media fill *** the *** RABS *** were observed to pass over the stopper bowl during assembly, over the stopper bowl and stoppers during change of environmental monitoring plates, and over open vials during removal of fallen vials in the incoming vial area.
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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.