On April 9, 1997, Mr. Mark Tseng and Mr. Emir Galevi of the United States (U.S.) Food and Drug Administration (FDA) conducted a pre-announced inspection of the computer monitor manufacturing facility, Daesun Industrial Co., Ltd., in Kyunggi-Do, South Korea. The FDA inspectors reported several serious deficiencies found in Daesun Industrial Co., Ltd.’s quality control and testing program for the certification of compliance of computer monitors with the United States (U.S.) Federal Performance Standard for Television Receivers, 21 CFR 1020.10. Based on their findings, the Center for Devices and Radiological Health (CDRH) believes that the current quality control and testing program at the Kyunggi-Do monitor factory is not fully adequate to assure that television products and monitors will comply with Federal performance standards and other applicable regulations.
Engineering Analysis and Phase III Radiation Testing for Selected Computer Monitors.
