FDA 483 - NYSARC, Columbia County Chapter, Inc. - May 13, 2022

An FDA inspection of NYSARC, Columbia County Chapter, Inc., a medical device manufacturer in Mellenville, NY, identified three significant observations. The firm lacked documentation for process validation of a packaging machine, maintained inadequate device history records with missing lot number information, and failed to include Unique Device Identifiers (UDI) in its device history records. These findings indicate deficiencies in the firm's quality system for medical device manufacturing.