Company: Med-Mart Pulmonary Services
Product: Inhalation solutions
Date: 9/30/02
Failure to perform routine calibration and to assure proper performance of all automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of a drug product [21 CFR 211.68]. For example, your filtration unit, _____ small batch filler unit, industrial scale, _____ Pump, and the _____ Machine used to fill, label, and seal drug products have not been calibrated or otherwise checked to ensure they perform their operations consistently and accurately.
FDA District: San Francisco District Office
