FDA 483 - Forge Medical Inc. - July 18, 2018

Forge Medical Inc., a medical device manufacturer in Bethlehem, PA, underwent an FDA inspection from July 3 to July 18, 2018. The inspection, documented in an FDA Form 483, identified five significant observations related to the company's quality system, indicating a need for improved adherence to regulatory requirements.

Key issues observed included inadequate procedures for process and specification changes. Specifically, modifications to the VasoStat Hemostasis Device packaging lacked documented evidence of review, approval, risk analysis, and necessary verification or validation studies. The firm also failed to maintain an approved Device Master Record for the VasoStat device, which should detail essential specifications and procedures.

Furthermore, corrective and preventive action (CAPA) activities were inadequately documented. A CAPA initiated for particulate matter in the VasoStat device remained incomplete, leading to recurring issues. Documentation of personnel training was also found deficient, particularly concerning the management representative's qualifications and experience. Finally, the evaluation of contract manufacturers for the VasoStat device lacked documented evidence, failing to demonstrate their ability to meet required specifications and quality standards.

Forge Medical Inc. acknowledged these observations and committed to implementing corrective actions for each identified deficiency, as required by the regulatory framework governing medical device quality systems.