Microbiology FDA 483 (Samsung Biologics): Revalidation of equipment is not performed at appropriate intervals
Observation
Facility Type
Firm / Company
Samsung Biologics Co. Ltd.
System
Details
Specifically,
(A) Your firm’s Quality Unit failed to ensure equipment is maintained and used within its validated state. For example:
ELISA Binding ID 150-FACS-003: was due for revalidation *** from the last revalidation which was performed on 03-Aug-2023. However. this equipment was observed being used past its revalidation due date. Your firm stated the equipment were not revalidated due to their respective grace periods granted by your procedure SOP-VAL-0016, Revalidation Program. Effective date: 07-JuI-2023, Version 51.0; however, you were unable to provide scientific justification to support the grace period.
(B) ***230-***-5311 used in Plant *** for *** sterilization of equipment and components for Fill line *** includes a*** supplied with ***, with the last *** sterilization process validated both physically and biologically, June 2020. The *** is not revalidated on a routine basis in assurance the validated state is maintained.
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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.