FDA 483 - GAELTEC DEVICES LTD - December 07, 2017

GAELTEC DEVICES LTD, a medical device manufacturer in Dunvegan, United Kingdom, was inspected by the FDA from December 4-7, 2017. The inspection resulted in an FDA Form 483, highlighting five significant observations indicating deficiencies in the firm's quality management system, as required under the Federal Food, Drug, and Cosmetic Act.

The main issues identified were a lack of established process validation procedures for critical manufacturing processes, where results cannot be fully verified. The firm's corrective and preventive action (CAPA) procedures were inadequate, failing to ensure the effectiveness verification of implemented corrective actions and lacking clear guidance for preventive actions. Complaint handling procedures were also deficient, with customer concerns outside the warranty period not being adequately managed, and complaints not consistently evaluated for potential Medical Device Report (MDR) submission. Furthermore, the inspection noted insufficient schedules for the maintenance of manufacturing equipment and inadequately established procedures for device history records.

GAELTEC DEVICES LTD is expected to address these observations by implementing comprehensive corrective actions to bring its operations into full compliance with regulatory requirements, as the Form 483 serves as notification of these quality system deficiencies.