Microbiology FDA 483 (Panacea Biotec): Failure to thoroughly review any unexplained discrepancy to meet any of its specifications
Observation
Facility Type
Firm / Company
Panacea Biotec Pharma Ltd.
System
Details
Specifically, non-viable monitoring excursions obtained during machine parts assembly of more than *** or *** successive events within *** were obtained during machines parts assembly in the following batches.
***, ***, ****, ****
None of these excursions have been investigated as a result of the film updating BFI-PD-079 Operation of Online Particle Counter procedure for machine parts assembly from: (requiring a deviation if the excursion *** or *** (successive events with a duration of *** in ***) to (requiring a deviation if excursions of the NV”PC particles occur more than *** events).
Record Date
FEI Number
Country
Citation Type
Audit Duration (Days)
Investigators
More observations from same firm / company
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.