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Medical Devices / Inspections and Audits

United Contact Lens Cited for Testing, Complaint Procedures

Jan. 11, 2017

United Contact Lens received a warning letter for failing to test finished products and establish written customer complaint procedures.

The FDA inspected United’s Arlington, Wash., facility in October and discovered that the firm failed to establish and maintain procedures to ensure that all purchased products and services conformed to specified requirements.

In particular, United did not establish purchasing control procedures for evaluating suppliers, contractors, and consultants. This is a repeat observation from a 2013 inspection. — Derek Major

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