The federal safety watchdog inspected the Monrovia facility from Nov. 14 last year through Feb. 4, finding 10 problems with the way Staar documents product changes and other issues, the company said in a regulatory filing.
The 10 problems noted by FDA inspectors "focus primarily on the need for adherence to and improved procedures, processes and documentation relating to design change, design transfer into specifications and production, verification and validation associated with device design and production, improvement in Good Documentation Practices, and broader environmental monitoring," Staar said.
The FDA last year issued a formal warning letter to California- and Switzerland-based Staar, citing the company for inadequate design protocols, quality control issues and its handling of patient complaints. The Monrovia plant makes Staar’s intraocular lenses. Shareholders later sued the company, alleging that Staar, president & CEO Barry Caldwell, ex-CFO Deborah Andrews and current CFO Stephen Brown "made false and/or misleading statements and/or failed to disclose" the problems at the plant in Monrovia. The Form 483 Staar revealed today stemmed from follow-up inspections made after the initial warning letter last year.
"Staar is currently drafting a response to the FDA’s observations and is concurrently continuing to develop and implement its corrective action plans relating to the 2014 warning letter and the Form 483. Staar takes the matters identified by FDA seriously and will continue to work diligently to address the observations identified in the Form 483 and 2014 warning letter. Staar has enhanced and continues to enhance its overall quality program as we focus on remediating all elements identified," the company said yesterday in the SEC filing.
STAA shares plunged earlier this year when the company predicted that its 4th-quarter and full-year revenue will fall below expectations, due to currency fluctuations and the inability to fill a number of orders by the end of 2014. The company is slated to release its full Q4 and 2014 results during the week of Feb. 23, according to the filing.