Recipient:Rite-Dent Manufacturing Corp
Product:Alginate impression material, zinc phosphate cement, polycarboxylate cement and other dental OTC devices
Date: 12/2/05

Your firm failed to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose(s) and is capable of producing valid results. Each manufacturer shall maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a) and 70(g)(1). There are no procedures regarding the calibration, inspection, checking, cleaning, and maintenance of the alginate impression material blender (FDA 483, Item #24); and there are no established schedules for cleaning/maintenance of any production equipment and no records are kept of such activities (FDA 483, Item #26).

FDA District:Florida District Office