The FDA issued Summit Medical a Form 483, citing issues with CAPA and incoming product acceptance procedures as well as process validation shortcomings.
The Eagan, Minnesota-based device manufacturer’s facility was inspected in late February. The agency found that the molding process used for numerous ventilation tube models was not adequately validated. The process was inadequate because no there was no product that met the requirements under the firm’s parameters. In addition, there was no mold qualification for a particular tube component.
The firm also failed to adequately establish CAPA procedures. The firm initiated corrective actions after receiving a previous Form 483, completing mold qualifications for ventilation tubes, and subsequently closed the CAPA after verifying effectiveness. However, the mold qualifications for certain part numbers contained results that failed to meet the requirements set forth by their engineering drawings, yet were deemed acceptable. The FDA ruled the CAPA to be ineffective.
In addition, the firm did not establish procedures for accepting incoming products. Certain inspection activities required to be performed for silicone tray inserts and mats were not documented.
Some supplies received by the facility were found to be nonconforming, and some were returned to the vendor. But some were used in the production and assembly of a product, the agency said.