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Medical Devices / Inspections and Audits

FDA Cites Washington Device Manufacturer for Document Control

Aug. 15, 2019

Camas, Washington-based Comfort Acrylics was hit with a Form 483 over problems with its document control procedures.

In an  April 18-19 inspection, the FDA investigator observed multiple documents in the firm’s quality management system binder that weren’t noted on the document control log.

Multiple revisions for documents were also seen without signatures in the QMS binder, although the firm required them on its document change forms. The documents were changed in April 2018.

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