FDAnews Device Daily Bulletin

Sometech Warning Letter Notes CAPA, Complaint Procedures

June 3, 2011
Korean devicemaker Sometech has received an FDA warning letter for violations related to corrective and preventive actions (CAPA), complaint handling and documentation procedures. During a Nov. 1 to Nov. 4, 2010, inspection of its Seoul, South Korea, facility, the FDA found Sometech failed to establish and maintain procedures for implementing CAPAs, according to the April 6 letter posted recently online. “All five CAPAs initiated in 2009 and 2010 for U.S. devices were reviewed and found deficient,” the letter says.
The GMP Letter