![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Devicemaker Gets Close-Out Letter on CAPA Woes at Taiwanese Plant
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
The GMP Letter
Upcoming Events
-
21Oct