FDA 483 - Unisis Corp. - May 18, 2023

An FDA inspection conducted at Unisis Corp., a medical device manufacturer located in Koshigaya, Saitama, Japan, from May 15-18, 2023, revealed several significant deficiencies in their quality system. The inspection findings, documented in an FDA Form 483, indicate non-compliance with the Federal Food, Drug, and Cosmetic Act, particularly concerning medical device quality system regulations.

Key observations include the absence of established design control procedures for Class II Uniever Disposable Epidural and Nerve Blocked Needles, and inadequately established procedures for corrective and preventive actions (CAPA). Furthermore, the company's device history records failed to demonstrate manufacturing in accordance with the device master record. Deficiencies were also noted in procedures for accepting in-process products and ensuring purchased products and services, including those from contract manufacturers, conform to specified requirements. This included a failure to evaluate contractors and ensure they were registered with the U.S. FDA for products sold in the U.S. market.

Unisis Corp. is required to address these observations by implementing comprehensive corrective actions to bring their operations into compliance with FDA quality system requirements for medical devices. The firm is responsible for conducting internal audits and rectifying all identified violations.