Monrovia, CA—Just months after STAAR Surgical Co. told investors it could face possible FDA enforcement action for 16 violations that turned up during inspections of its Monrovia plant, the company said it has resolved all but two observations.
Monrovia, CA-Just months after STAAR Surgical Co. told investors it could face possible FDA enforcement action for 16 violations that turned up during inspections of its Monrovia plant, the company said it has resolved all but two observations.
STAAR Surgical officials announced Sept. 14 that the FDA issued three inspectional observations, and one of those was marked "corrected and verified." The company said it has pledged to correct the remaining two observations.
Charles Kaufman, the company's legal counsel, declined to elaborate on the nature of those issues with Ophthalmology Times. "I think people understand that there's certainly a big change from what we had last time," Kaufman said.
"The company believes the outcome of the inspection reflects the company's efforts to enhance its compliance systems over the past 20 months and the FDA's evaluation of that work," according to STAAR Surgical's disclosure filed with the Securities and Exchange Commission.
Analysts and other industry observers were concerned that any violations pending at the Monrovia plant might interfere with the FDA approval of the company's Visian ICL, which earned an approvable letter from the FDA on July 28 (Ophthalmology Times, Aug. 15, 2005). A final approvable letter from the FDA remains subject to a review of the most recent inspection results by the FDA's Center for Devices and Radiological Health.
The company has been dealing with issues relating to the FDA inspections since December 2003 (Ophthalmology Times, Feb. 1, 2004).
A September 2004 report from the FDA criticized production and process controls, corrective and preventive action, quality-system requirements, statistical techniques, complaint handling, medical device reporting, design controls, acceptance criteria, and document controls and records. In a June 30, 2005 letter, the FDA said it was "gravely concerned about STAAR's serious, continuing violations and is prepared to seek the appropriate remedies" under the Federal Food, Drug, and Cosmetic Act.
Kaufman credits the turnaround to the company's reaction to FDA criticisms, he said.
"What we tried to do proactively was what the FDA would have done if (it) had taken the first steps of an enforcement action," he said. For example, the FDA might have required an observer to watch over the company's methods and recommend changes, or halted production for a time, he added.
The company invited Quintiles-a North Carolina-based company the FDA often uses as a court-ordered observer-to help improve its systems. STAAR Surgical also took some products offline-Kaufman pointed to the Collamer 3-piece IOL and its injector-while they were revalidated. Both are back online, he said.
The Quintiles recommendations were implemented before enforcement was necessary, Kaufman said. "I think, ultimately, that's what's gotten us to this point," he said.