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Medical Devices / Inspections and Audits

New York Devicemaker Cited for Software Validation, CAPA Violations

April 9, 2019

The FDA hit Honeoye Falls, New York device manufacturer Micropen Technologies with a Form 483 over violations at its facility, including issues with software validation and CAPAs. Micropen’s devices are used for applying protective overcoats and undercoats.

During a Nov. 13-14, 2018 inspection, the agency noted failures by the manufacturer to validate that corrective actions had been effective. Specifically, two of 11 CAPAs lacked verifications, and one of the two did not include a validation that the corrective actions didn’t adversely impact the finished device.

The firm also used software to operate the micropens without validating it for its intended use.

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