Vitalograph Ltd., 6-Aug-99, Spirometers and peak flow meters 4. Failure to establish and maintain process control procedures for the monitoring and control of process parameters during production, as required by 21 CFR 820.70(a) and (b). For example, the firm failed to measure the temperature of the wave-soldering machine at the start of every PCB Kit...Read More

Drager Medizintechnik GmbH, 6-Aug-99, Intensive care ventilators, anesthesia and incubators 1. Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a “Hit List” of top nonconforming components...Read More