FDA EIR - Trividia Manufacturing Solutions, Inc. - November 07, 2018

A routine FDA inspection of Trividia Manufacturing Solutions, Inc., a contract medical device manufacturer, took place from November 5-7, 2018. Conducted under Medical Device Level I inspection guidance (Compliance Program 7382.845A), the review focused on the firm's compliance with medical device regulatory requirements. The inspection identified one significant observation detailed on an FDA-483 form. The main violation was that the company's procedures for corrective and preventive actions (CAPA) were not adequately established. Specifically, the firm failed to document the effectiveness of two Medical Device Corrective Action Requests (CAR #465 and #477) prior to their closure, a direct non-compliance with 21 CFR 820.100(a)(b), which requires verifying and documenting the effectiveness of such actions. Management at Trividia Manufacturing Solutions, Inc. acknowledged the observation and committed to rectifying the issue. The FDA requested a written response within 15 business days, noting that further regulatory action could be pursued if the findings were not corrected. Additionally, discussions were held regarding ensuring labeling compliance for specific products, and the firm was encouraged to remain vigilant in maintaining quality system requirements.