FDAnews Device Daily Bulletin

FDA Cites Jensen Industries for CAPA, Quality System Issues

Aug. 1, 2017

Jensen Industries landed a Form 483 over problems with its corrective/preventive actions and quality system reviews.

The FDA issued the form following a March inspection of the firm’s North Haven, Conn., facility. According to the agency, Jensen failed to follow its SOPs on corrective/preventive actions (CAPA). A CAPA initiated in July 2015, for example, failed to document the effectiveness of the action the company took in the specified time frame, while two CAPA actions opened in 2016 are still open past their due dates of February 2017, with no documentation justifying the continued openness.

Inspectors found executive managers did not review Jensen’s quality system, in contrast with the firm’s SOPs, which require regular management reviews. In one case, the firm conceded one of the management reviews was not performed according to the established schedule. Jensen promised to correct both observations.

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