FDAnews
www.fdanews.com/articles/191845-fda-cites-indiana-devicemaker-for-capas-mdrs

FDA Cites Indiana Devicemaker for CAPAs, MDRs

July 1, 2019

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.

View today's stories