Devicemaker Gets Close-Out Letter on CAPA Woes at Taiwanese Plant

March 20, 2013
A mobility device company has resolved multiple corrective and preventive action (CAPA) and quality systems violations, earning it a close-out letter from the FDA. Merits Health Products received an eight-observation warning letter in November 2011, following a July inspection of the company’s main factory in Taichung, Taiwan.
The GMP Letter