Novartis gets FDA warning letter for Puerto Rico plant
A manufacturing facility operated by Novartis subsidiary Ciba Vision in Puerto Rico has been cited for manufacturing quality violations and sterility issues by the FDA, which has just posted a warning letter to the company on its website.
The letter follows two inspections of the plant in El Jibaro Industrial Park in July and September 2010 by FDA staff which resulted in a Form 483 detailing various violations which needed to be corrected.
Specifically, the inspectors found faults with the procedures followed for testing bioburden and sterility of products made at the unit, including various types of contact lens, as well as labelling inconsistency problems.
The company "failed to provide data that could support that the actual methods you used for the recovery of microorganisms from your products during bioburden determination and sterility tests are effective", says the letter, which is posted here.
Ciba Vision issued a recall of all SoftPerm daily wear contact lenses last October, saying that it had identified that the sterility of the product had been compromised, which could cause eye infections. The company also said that the pH of the storage solution may be out of specification, which could cause a burning or stinging sensation when the lenses are applied.
The company's attempts to address the FDA's concerns were deemed unsuccessful, according to the letter which is dated 21 December 2010. An investigation into the sterility issues affecting the SoftPerm contact lenses which concluded that the offending sterility tests were all false positives was "inadequate", according to the agency.
The FDA also takes issue with Ciba Vision's continued use of two contract laboratories that provided sterility testing services even after audits indicated they were using "poor aspetic techniques".
The letter indicates that Ciba Vision is no longer manufacturing the SoftPerm product at the plant.