FDA 483 - Almark Tool & Manufacturing Company, Inc. - February 07, 2023

An FDA inspection of Almark Tool & Manufacturing Company, Inc. in Garwood, NJ, revealed significant deficiencies in their quality system. The firm lacked established procedures for critical areas such as complaint handling, device history and master records, equipment calibration and maintenance, employee training, and medical device reporting. These findings indicate a broad failure to implement essential controls for medical device manufacturing.