CooperVision Cited for Investigations; FDA Requests Staff Training

June 20, 2014

CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. While the company will need to improve staff training, the letter should not hurt operations or approvals, an analyst says.

According to the Feb. 27 letter, the contact lens maker’s corrective and preventive action investigations did not evaluate the impact of reported problems on the affected device, or on affected products in commercial distribution. The company also lacked interim controls to implement while corrective actions were in progress, the letter says. The letter, which followed a Dec. 10, 2013, to Jan. 10 inspection by the FDA’s San Juan district office, was recently posted on the agency’s website.

Another CAPA investigation followed complaints about power failures for distributed ProClear One Day lenses. The company confirmed the complaints and found that devices were released for distribution while not in compliance with the labeled power specification. “We are concerned when a firm uses the product’s end-user as quality control based on use discomfort resulting in visual acuity disturbance,” the letter says.

While the warning letter will necessitate better staff training, it is unlikely to require significant spending or lead to any product recalls, says Wells Fargo analyst Larry Biegelsen. He notes the training “could take some time to execute,” but the company expects to be ready for reinspection within the next two months.

CooperVision “has already responded to many of the violations in the WL and much of the remaining outstanding issues are administrative in nature,” Biegelsen says. “The bottom-line is that the WL is unlikely to affect ongoing plant operations or potential new product approvals.”

In addition to problems with investigations, the FDA cites timeliness issues with a December 2011 CAPA related to metallic particles found during in-process testing of lenses. “We find it objectionable that containment activities were not implemented until October 2012, and the risk assessment was not finalized until 09/13/13,” the letter says. “This CAPA was closed on 09/16/13, without revising the FMEA addressing the presence of particulate matter, categorized as a ‘minor’ defect.”

CooperVision also failed to justify its categorization of the defect as minor and did not conduct a scientific assessment of the defect for devices in commercial distribution, the letter notes. The FDA raises concerns with CooperVision’s defects classification system and recommends reassessment of the company’s controls for establishing and classifying product defects.

While the company’s postinspection response indicated that no complaints had been reported for the particulate issue, the FDA points out that metallic particles could still be present in distributed devices due to ineffective corrective actions. “Bear in mind that your current in-process controls might allow for the release of devices with particulate matter without requiring the identification of particulate matter as part of your investigation,” the letter says.

Another CAPA investigation into particulate matter in products distributed in Japan was not extended to other devices that shared the same raw materials and manufacturing equipment, according to the letter. These devices were distributed to the U.S. market.

The FDA investigator also reviewed CooperVision’s CAPA SOP, finding it lacked timeframes for completing investigations based on a revised risk classification, implementing subsequent corrective and preventive actions and verifying effectiveness. “It also failed to provide specific instructions for conducting risk assessments, Health Hazard Evaluations, and the containment of product when the criticality of the problem merits due diligence,” the letter says.

CooperVision did not respond to a request for comment by press time.

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