Browse Physiological apparatus topic

Inspection subtopic

Articles 1-15 out of 15 article(s) Title Author Type Date Words St. Jude used unsupported processes in catheter manufacturing, FDA says. Mashaw, Rebecca May 1, 2009 378 Preparing for FDA BIMO inspections: an industry expert shares tips and useful data for developing a quality-systems approach for conducting medical device clinical trials. Rockwell, Susan M. Nov 1, 2008 1023 When equipment malfunctions. Williams, Linda Apr 1, 2008 1547 GAO report scolds FDA inspections performance; Dingell subpoenas von Eschenbach, others regarding Ketek. Feb 1, 2008 740 Utah Medical Products slapped with two 483s in consecutive years; firm sues agency. Dec 1, 2006 1284 Bausch & Lomb Clarifies Reporting of Fusarium Keratitis Cases to FDA. May 17, 2006 871 Medicare: More Effective Screening and Stronger Enrollment Standards Needed for Medical Equipment Suppliers. Jan 1, 2006 610 Encore Medical receives 9-item 483 citing quality system; audits, unvalidated design changes. Pickett, Joseph Nov 1, 2005 780 Audiology equipment manufacturer fails to implement quality system. Oct 1, 2005 849 Wood Hygienic inspected for selling colonic units without PMA, netting 8-item 483. Oct 1, 2005 379 VNS therapy is approved for severe depression: strict conditions placed on use of device. Splete, Heidi Aug 1, 2005 917 Pre-approval inspection results in 12-item 483 for E Med Future. Jul 1, 2005 682 Audit of Novo Nordisk initiated for consumer complaints results in no 483 issued. Jun 1, 2005 917 Medical Department PMS. Jul 1, 2004 586 Medical devices. Sep 22, 2003 800