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Medical Devices / Inspections and Audits

FDA Raps OptumHealth Care Solutions Over Quality Audits

Aug. 8, 2018

The FDA found design verification and quality audit deviations in a February/March inspection OptumHealth Care Solutions facility in Rye Brook, New York.

Investigators found the firm had no procedure in place requiring the company to review the results of its contract firm’s verification activities. The contract firm also had no documentation demonstrating it had reviewed the design verification it provided.

The firm’s procedures for design revisions also did not define what is considered a “major” or “minor” change, according to the 483, relying instead on a contract firm’s definition, which the agency deemed inadequate.

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