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Medical Devices / Inspections and Audits

Michigan Devicemaker Warned for CAPA Documentation

May 22, 2019

The FDA hit Michigan devicemaker Orchid Orthopedic Solutions with a warning letter over its procedures for implementing CAPAs.

The Feb. 4-15 inspection of the Farmington Hills device manufacturer revealed deficiencies in the company’s CAPA procedures. Specifically, a change in the corrective plan for water system monitoring procedures was not documented in the CAPA form.

The investigator also found that Orchid failed to regularly analyze rework shop orders—to repair or rebuild product that didn’t meet specifications—as a source of quality data to identify potentially recurring quality problems.

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