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Medical Devices / Inspections and Audits

FDA Cites Indiana Devicemaker for CAPAs, MDRs

July 2, 2019
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The FDA hit Ossian, Indiana device manufacturer Haven Manufacturing for violations at its facility, including a lack of documented evidence for CAPA effectiveness.

The agency noticed during its Feb. 5-7 inspection that none of the eleven reviewed CAPAs had evidence demonstrating they were successful.

Additionally, the company referenced a standard operating procedure that had been obsolete for over 12 years and had no written procedures for medical device reporting.

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