FDAnews Device Daily Bulletin

Sometech Warning Letter Notes CAPA, Complaint Procedures

June 3, 2011
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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