The QMN Weekly Bulletin
Quality / Medical Devices / Inspections and Audits

Lensmaker’s GMP, CAPA Violations Bring Warning Letter from FDA

June 5, 2015
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A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter.

The letter, posted April 3, says Visionary Contact Lens of Anaheim, Calif., violated established protocol by not adequately validating software for its intended use. It cites Visionary’s failure to validate its CNC Lathe software, used in manufacturing, and the MAS 90 software used in labeling.

The FDA challenges Visionary for not ensuring that all of its manufacturing equipment met specified requirements and was appropriately placed and installed.

Additionally, verification and validation was deficient in the company’s corrective and preventive action procedures. The company didn’t investigate the cause of nonconforming products and other quality problems, the letter says.

Visionary also didn’t identify actions needed to correct these problems. The FDA points to nonconformance reports from December 2014 and January 2015, saying the reports lacked evidence an investigation was done or corrective action was implemented.

The FDA goes on to say that Visionary failed to conduct quality audits from 2011 through 2014 and, according to several records, failed to train employees in GMP, CAPA and other procedures to ensure quality.

The devicemaker is making corrections to ensure there will be no recurrence, a spokesman said. The FDA asks that manufacturers respond to Form 483s within 15 business days and address each observation with either a timeline for correction or a request for further clarification on what action should be taken. The responses are not formally required, but often help prevent warning letters like the one issued to Visionary.

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