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Failure to establish procedures for design changes and for acceptance of incoming product, were among the quality management lapses uncovered during a May 13-16 FDA inspection of Vasamed’s Eden Prairie, Minnesota plant. Read More
Management at Hospital Therapy Products failed to establish a quality plan, quality audits, or procedures for management reviews, a May 7-14 inspection of the firm’s Wood Dale, Illinois inspection revealed. Read More
Additionally, the calibration procedure had no arrangements for including an evaluation of adverse effects on a device’s quality when testing equipment is found to be out-of-calibration. Read More