Some of the employees at the CIBA Vision facility in Cidra, Puerto Rico, appear to have trouble seeing straight. The FDA recently sent a warning letter to the unit, which makes contact lenses, for failing to notice inconsistent product labeling. Moreover, the short-sighted staff also continued to use two contract labs even after determinng the companies were responsible for earlier sterility failures.

“During the period of March through May 2010 your firm opened three CAPAs (corrective and preventive actions) to address issues related to distributed products which had labeling inconsistencies. These deficiencies were not detected by your quality inspectors even though your procedures require that quality assurance inspectors verify if the label rolls have the correct expiration date, bar code reading, and that the product complies with specifications,” the FDA wrote in its December 2010 letter, which was just posted on the agency web site.

Later the FDA added this: “Your investigation indicates that audits conducted at these contract laboratories in 2008 demonstrated poor aseptic techniques. We find objectionable that despite these findings, you continued using these contract laboratories to conduct the sterility testing of all your products without ensuring that they had implemented adequate corrective actions to the deficiencies identified during your audit.”

Of course, Puerto Rico can be a small world and relationships are important. And Novartis has since stopped making the SoftPerm brand mentioned in the letter (see this). Nonetheless, the infractions suggest Novartis should make sure its employees are getting their eyes checked, so they can spot labeling differences and also see clearly when it comes to giving work to labs that are unable to perform basic sterility tests.