Biomerics AlajuelaMay 5, 2023

FDA 483 - Biomerics Alajuela - May 05, 2023

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Record Details

An FDA inspection of Precision Concepts Costa Rica S.A., a medical device contract manufacturer, revealed one observation concerning inadequate procedures for finished device acceptance. This indicates a deficiency in the firm's quality system regarding product release controls.

Company: Biomerics Alajuela
Inspection Date: May 5, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Matthew D. Schnittker

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ID · 791e4ee7-f240-4764-a9c4-0ef55dbdcd68