Supplier Evaluation, Calibration Issues Bring Custom Ocular a 483

Inadequate procedures for evaluating suppliers and calibrating equipment resulted in a Form 483 for Custom Ocular Prosthetics.

The 483 — issued after a July 15 inspection of the company’s Seattle, Wash., facility — says Custom Ocular didn’t define how suppliers are to be evaluated and what controls are required to ensure its products conform to specified requirements. The devicemaker also failed to document supplier evaluations.

Custom Ocular also lacked procedures to ensure that equipment is routinely calibrated, specifically pressure gauges and thermometers used to monitor laminator jacks, the 483 says.

The devicemaker was also cited for its document control procedures because documents lacked signatures and dates. The 483 also says Custom Ocular couldn’t provide documentation showing that management reviews had been conducted.

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