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Medical Devices / Inspections and Audits

Hemodialysis Solution Maker Hit for Recurring Quality Failures

Dec. 17, 2018
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A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection.

The quality failures included inadequate process control procedures to ensure conformance to specifications, inadequate testing and validation procedures, inadequate finished device acceptance activities and failure to document rework and reevaluation activities.

The firm had received a July 12, 2017, warning letter from the agency for missing product nonconformity reports and failure to investigate nonconforming products.

Many of the inspection findings were repeat observations, flagging document control procedures, labeling activities, and measuring and test equipment not suitable for the intended purpose.

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