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Medical Devices / Inspections and Audits

Electro Cap International Cited for Validation, Rework Failures

July 5, 2018

Failure to validate its products and undefined rework of nonconforming product, as well as other quality system failures, landed Electro Cap International a Form 483 following a March 2018 inspection of its Eaton, Ohio facility.

The firm failed to validate its induction sealer that was installed in February 2015 and is used for sealing its Electro-Gel jars. 

The FDA inspectors noted that five of eight product nonconformity reports included rework processes for the firm’s electro caps but the rework processes were not defined or approved.

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