FDA 483 - Precision Concepts Costa Rica S.A. - May 05, 2023

An FDA inspection of Precision Concepts Costa Rica S.A., a medical device contract manufacturer, took place from May 2nd to May 5th, 2023. The inspection resulted in the issuance of a Form FDA 483, identifying an observation related to the firm's quality system.

The main issue observed was that procedures for finished device acceptance had not been adequately established. Specifically, a deficiency was noted in one of eleven final audits pertaining to process -10-600S, Revision C. This indicates a gap in the company's controls for ensuring medical devices meet quality specifications before release.

Operating under the regulatory framework of the Federal Food, Drug and Cosmetic Act, firms like Precision Concepts Costa Rica S.A. are required to maintain robust quality systems. The FDA 483 serves as notification of these observations, expecting the firm to address them. Precision Concepts Costa Rica S.A. has acknowledged the observation and promised to implement corrective actions. The company is responsible for conducting thorough self-audits and providing a comprehensive response outlining their corrective and preventive measures to ensure full compliance with regulatory requirements.