Novartis Handed Form 483 Over Former Vaccine Manufacturing Site
A flu vaccine manufacturing site that was recently transferred from Novartis to CSL Limited received an FDA Form 483 for problems with cleaning equipment, stability studies, batch certification and other issues.
Poor cleaning and sanitation controls for equipment used to manufacture the Fluvirin vaccine resulted in one out-of-specification batch and 22 batches with elevated endotoxins, six of which were rejected, the form notes. The plant also failed to validate the adequacy of its cleaning validation processes. The citations followed a June 1 to 11 inspection of the Liverpool, England, plant.
Novartis’ investigation of the elevated endotoxins was also incomplete, so no CAPA was initiated that would prevent a repeat of the problem, the 483 says.
Of the 19 CAPAs that were opened because of OOS batches, five were not closed in a timely manner to prevent reoccurrence. Some didn’t close up to a year later.
Finally, investigations of Fluvarin potency assay test results for OOS, out-of-expectation and out-of-trend results were inadequate, the 483 says.
The facility, which was owned and operated by Novartis when the inspection and issues occurred, was officially divested to Australian drugmaker CSL on July 31, Novartis spokeswoman Liz Power said. The $275 million sale was part of Novartis’ decision to shift from vaccines and focus on novel pharmaceuticals, eye care and generics.
View the Form 483 at www.fdanews.com/09-03-15-NovartisVaccines.pdf. — Kellen Owings