Chiu Technical warned for CAPAs.During an inspection of Chin Technical between April 19 and May 1 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. determined the manufacturing of The Transilluminator, Model BFO-150, was is in violation VIOLATION. An act done unlawfully and with force. In the English stat. of 25 E. III., st. 5, c. 2, it is declared to be high treason in any person who shall violate the king's companion; and it is equally high treason in her to suffer willingly such violation. of Quality Systems/GMP regulations, including failure to establish and maintain QS procedures and instructions. For example, FDA said in the Sept. 24 letter that the firm did not establish and maintain quality system procedures for complaint handling; CAPA CAPA California Alternate Performance Assessment CAPA Captaris, Inc (stock symbol) CAPA Confederation of Asian and Pacific Accountants CAPA Creative and Performing Arts (school) ; non-conforming products; and acceptance activities. In addition, the company failed to establish and maintain procedures for management review. FDA wrote: "The firm did not establish and maintain procedures for management review to ensure that the quality system is maintained. There was also a failure to establish procedures for quality audits and to conduct such audits. Specifically, there were no reports showing the firm conducted internal quality system audits." Chiu Technical did not maintain device master records. For example, it did not have a Device Master Record for the Transilluminator that contained or identified the location of the device and component specifications, and other required information for the manufacturing processes. The inspection also found a failure to establish and maintain device history records and the Transilluminator Model BFO-150 is misbranded mis·brand tr.v. mis·brand·ed, mis·brand·ing, mis·brands To brand or label misleadingly or fraudulently. Adj. 1. because the firm failed or refused to furnish fur·nish tr.v. fur·nished, fur·nish·ing, fur·nish·es 1. To equip with what is needed, especially to provide furniture for. 2. material or information that is required by MDR MDR, n See multidrug resistance. MDR, n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration. regulation. 14242W |
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