Radiologicals/mammography.12468W Diagnostic Imaging, Bloomington, IL, May 15 (Chicago). The letter maintained that an X-ray system manufactured by Diagnostic on Aug. 16, 2002, did not comply with federal Performance Standards in that the difference between the indicated source to image receptor distance (SID) and the actual SID was measured to be greater than 2%. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. notified Diagnostic Imaging that if it determined the deviation DEVIATION, insurance, contracts. A voluntary departure, without necessity, or any reasonable cause, from the regular and usual course of the voyage insured. 2. was caused by improper assembly or installation, it needed to correct the deviation at no charge to the user, or if it determined the deviation was caused by the factory-based manufacturer, it needed to notify the latter. However, the agency stated that if Diagnostic could establish that the system is compliant and that "the alleged deviation and/or defect does not exist or does not relate to the safety of the product, or is directly attributable to user abuse or lack of maintenance," it could submit such evidence to the agency. An unnamed investigator inspected the device at an undisclosed location Nov. 19, 2002. 12469W Tatung Company Tatung Company, also known as Tatung, is a multinational corporation established in 1918 and headquartered in Taipei, Taiwan. Tatung also maintains a regional headquarters in Long Beach, California for the U.S. market. of America, Long Beach, CA, May 16 (CDRH-OC). Following a March 11, inspection by investigators Joseph Teixeira and Dawn Braswell, FDA disapproved of the firm's microwave oven quality control and testing program. "Microwave emission tests were not performed correctly," the agency stated, noting that the maintenance and calibration calibration /cal·i·bra·tion/ (kal?i-bra´shun) determination of the accuracy of an instrument, usually by measurement of its variation from a standard, to ascertain necessary correction factors. of microwave compliance survey instruments were not performed properly. Specifically, the firm's Local Calibration Reference (LCR See least cost routing. ) Holaday meter was "beyond its scheduled calibration date." The agency also objected to the firm practice of whiting out and overwriting Overwriting An options strategy that involves the sale of call or put options on stocks that are believed to be overpriced or underpriced. The options are not expected to be exercised. Notes: Also referred to as overriding. entries in final quality control test records. Cal, OC/QS |
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