Company: The Soule Co. Inc.
Product:Rapid Foam and other styrofoam products
Date: 9/15/04
Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results and all activities are documented as required by 21 CFR 820.72(a). Your firm lacks procedures to ensure that equipment is calibrated according to a specified schedule and that all activities are properly documented (FDA 483; Item #18 & 19).
FDA District: Florida District Office
