483
NYSARC, Columbia County Chapter, Inc.NYSARC, Columbia County Chapter, Inc. – FDA 483, May 13, 2022
Record Details
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.
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ID · 7f0d1145-dc6e-4163-80c9-56159e1a9fc7
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