Biolase Technology, Irvine, CA, Sept. 5 (Los Angeles).During an 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. investigation Aug. 8-Aug. 17, the agency determined that the manufacturer and marketer of medical and dental lasers A dental laser is a type of laser designed specifically for use in oral surgery. In the United States, the use of lasers on the gums was first approved by the Food and Drug Administration in the early 1990s, and use on hard tissue like teeth or the bone of the mandible gained was not in conformance con·for·mance n. Conformity. Noun 1. conformance - correspondence in form or appearance conformity agreement, correspondence - compatibility of observations; "there was no agreement between theory and with the current GMP GMP (guanosine monophosphate): see guanine. requirements for medical devices. Significant violations included failure to ensure that management with executive responsibility had established an effective QS. Specifically, there were no QS internal quality audits performed from September 2004 until February 2006; and, the firm's design-output procedures did not allow for adequate evaluation of conformance to design-input requirements. For example, FDA pointed out that the software requirement input specifications for the Waterlase MD dental laser could not be individually verified and documented to show conformance to the corresponding functional outputs. Furthermore, the agency stressed that the design transfer procedures Transfer Procedures The procedure by which ownership of a stock moves from one party to another. The transfer agent follows a detailed, documented series of steps governed by the SEC to ensure that a transaction has been completed. did not include explicit instructions to transfer the software requirement specifications to production. Additionally, not all of the actions needed to correct and prevent the recurrence of non-conforming product and other quality problems were identified by the firm, as required; and not all complaints were reviewed and evaluated to determine whether an investigation was necessary. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the warning letter, at least 325 customer complaints dating back to Oct. 13, 2005, had not been evaluated to determine if an investigation was necessary. CAPA CAPA California Alternate Performance Assessment CAPA Captaris, Inc (stock symbol) CAPA Confederation of Asian and Pacific Accountants CAPA Creative and Performing Arts (school) , C-H, Comp/Soft, Design, QC/QS; Doc. 13967W Biolase Technology: [check] Neglected to ensure that management with executive responsibility had established an effective QS. [check] Failed to ensure that software requirement input specifications could be individually verified and documented to show conformance to the corresponding functional output requirements. [check] Neglected to ensure that all complaints were evaluated to determine whether an investigation was necessary. |
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