483
CSA MedicalFDA 483 - CSA Medical - March 23, 2026
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Record Details
An FDA inspection of CSA Medical, Inc. in Lexington, MA, conducted from March 17-23, 2026, identified deficiencies in the firm's quality system. The primary issue concerned inadequate documentation of procedures and files related to nonconforming products. Specifically, nonconforming files lacked proper justification for corrective actions, determination of required actions, and evidence of trending.
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ID · d618c937-e4f5-4065-b605-a31bbfc2b80a