Intraocular lens maker Staar Surgical ($STAA) was hit by an FDA warning letter over compliance with Good Manufacturing Practices at its plant in Monrovia, CA.
The company says that on Feb. 4 the FDA issued a Form 483 warning letter with 10 observations.
"The observations 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 says in a Feb. 10 SEC filing.
The inspection was a follow-up to a 2014 warning letter and a form of post-approval monitoring following the FDA's approval of the Monrovia facility as an alternate manufacturing site for the company's ICL lens, the filing states.
Last year, shareholders sued Staar CEO Barry Caldwell and other company officials for making false or misleading statements and/or failure to disclose the issues at the Monrovia facility, MassDevice reports.
"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 says.
But it warns, "there can be no assurance that the FDA will be satisfied with the Company's response. Unless and until STAAR is able to correct outstanding issues to the FDA's satisfaction, the FDA may withhold approval of new products such as the Toric ICL (TICL) or take additional regulatory or legal action against the Company."
The FDA's Ophthalmic Devices Panel endorsed Staar's Visian Toric Implantable Collamer Lens (TICL) to treat myopia and astigmatism in March 2014, but the company still awaits final FDA approval.
Staar's stock has plunged about 75 cents on the news and currently trades around $6.70.
- read the SEC filing
- here's MassDevice's take