Microbiology FDA 483 : Environmental/personnel monitoring – RABS filling line
Observation
Facility Type
Firm / Company
Alvotech HF
System
Details
On Month, * 24, during RABSĀ setup activities, the first-air operator was observed sanitizing *** multiple times during each of the ***RABS interventions operations *** the *** RABS filling line have *** monitored via *** (for critical *** RABS Interventions). Frequent sanitization of operators *** during critical RABS operations may impact microbial data collection and analysis.
RABS *** monitoring is performed only *** of the RABS ***. RABS *** may be used *** at multiple RABS *** should be monitored as the are used.
Record Date
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Country
Citation Type
Audit Duration (Days)
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More observations from same firm / company
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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.