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Medical Devices / Inspections and Audits

Lack of Corrective Action Procedures Earn Hansen Ophthalmic Form 483

Jan. 3, 2017

Hansen Ophthalmic Development Lab, Inc., received a Form 483 for not establishing procedures for corrective and preventive action, and for not maintaining a complete device history record.

Inspectors visited Hansen’s Coralville, Iowa, facility in October and found that the company had failed to establish and implement procedures to document corrective actions from identified quality system deviations and other sources. — Jeff Kinney

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