The FDA cited Novartis’ Vaccines and Diagnostics facility in Liverpool, UK, for lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11.
During the June 1 to June 11 inspection, investigators noted out-of-specification results and endotoxin excursions in the Fluviron monovalent vaccine that had been occurring “intermittently” since 2012.
An investigation concluded that equipment maintenance and cleaning were inadequate and caused the contamination, and a maintenance schedule was updated as corrective action. But it was deemed inadequate because product residues were not taken into consideration as a possible cause of contamination. There also was no documentation that cleaning processes were validated.
In addition, the list of product deviations and non-conformances did not accurately reflect the actual numbers of non-conformances.
Novartis did not respond to a request for comment.
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