The QMN Weekly Bulletin
Quality / Medical Devices / Inspections and Audits

Four Devicemakers Cited for Inadequate Procedures

June 30, 2017

The FDA cited Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques over problems with their CAPA procedures, complaint handling and MDRs.

Jensen Industries drew a Form 483 over CAPA issues and quality system reviews, following a March inspection of the firm’s North Haven, Conn., facility. According to the agency, Jensen failed to follow its SOPs on corrective and preventive actions. 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 were still open past their due dates of February 2017. In addition, inspectors found managers did not review Jensen’s quality system, as required by the firm’s SOPs.

The FDA hit Tyson Bioresearch with a Form 483 for several of its procedures, including corrective actions, complaints, validation processes and written MDRs, following a March inspection of its facility in Chun-Nan, Taiwan. According to inspectors, the facility failed to initiate certain corrective and preventive actions in 2015 and 2016.

The FDA issued a Form 483 to OsteoSymbionics for numerous procedural problems with corrective/preventive activities, nonconforming materials and equipment calibration, following a March inspection of its Cleveland facility. According to FDA investigators, the firm had not completed a corrective/preventive action opened in June 2015, and there was no documented evidence the CAPA took place.

Innovative Sterilization Technologies landed an FDA Form 483 over inadequate corrective/preventive action (CAPA) procedures, complaint handling, MDR procedures and incoming product acceptance, following an inspection of the company’s Dayton. The facility’s complaints procedure did not define how to document complaint investigations or closures of warranty complaints for products that were not returned for assessment. Since last July, the company has “voided” nearly 50 warranty complaints because no product was returned.

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