Tegra Medical Costa Rica Sa – FDA EIR, May 18, 2017

An FDA Level II inspection of Tegra Medical Costa Rica Sa, a contract medical device manufacturer, was conducted from May 15-18, 2017. The inspection, carried out under the Quality System Inspection Technique (QSIT) Guide and Compliance Program 7382.845, focused on management controls, corrective and preventive actions (CAPA), and production and process controls. This was the facility's initial FDA inspection. Upon conclusion, a three-item Form FDA 483 was issued to General Manager Mr. Sean Mikus, outlining significant observations. The primary violations included: 1) Inadequate Corrective and Preventive Action (CAPA) procedures: The company failed to establish effective CAPA procedures, evidenced by recurring quality problems despite previous corrective actions and a consistent failure to meet established CAPA due dates. These issues relate to fundamental quality system requirements for addressing and preventing nonconformities. 2) Insufficient Process Validation: A critical laser welding process, whose results cannot be fully verified by subsequent inspection, was not adequately validated according to the firm's own established procedures. Furthermore, associated validation documentation was found to be inaccurate and not properly updated. This contravenes requirements for ensuring processes consistently produce quality products. 3) Deficient Equipment Maintenance: Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules were not adequately established. The inspection revealed a lack of documented evidence for these inspections and repeated failures to meet preventive maintenance due dates for essential manufacturing equipment. Mr. Mikus acknowledged these observations, stating a commitment to correct them. The inspection underscores the necessity for comprehensive and diligently followed quality system processes for compliance and product quality assurance.