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Medical Devices / Inspections and Audits

Pontis Draws FDA’s Attention for CAPA, Quality Violations

Oct. 5, 2018

The FDA faulted Pontis Therapeutics for its CAPA procedures, risk analysis and quality audits following a June/July inspection of the device manufacturer’s San Francisco facility.

The FDA reviewed 17 CAPA records from 2014 to 2016 and found that 12 of them had no effectiveness verification, and two CAPA records initiated in 2015 were still open. The company’s chief operating officer said the firm does not verify or validate corrective or preventive actions.

The company failed to perform quality audits at defined intervals to determine compliance and management with executive responsibility had not reviewed the quality system’s suitability and effectiveness at defined intervals, the agency found.

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