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.