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Medical Devices / Inspections and Audits

Zevex Cited for Inadequate CAPA, Nonconforming Product Rework

Dec. 14, 2018

Inadequate corrective and preventive action procedures and improper procedures for rework of nonconforming product landed devicemaker Zevek in hot water with the FDA following a Sept. 4 to Sept. 17 inspection of its Salt Lake City, Utah plant.

The firm designs and manufactures components for enteral nutrition delivery as well as surgical equipment.

FDA inspectors noted that several nonconforming products originally passed final acceptance when values did not agree with specifications.

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