Company: Dale Dental Inc.
Product: Dental porcelain powder
Date: 10/14/04
Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained and that calibration records are maintained [21 CFR 820.72(a) and (b)(2)] [FDA483 Item 5]. For example, your firm has no procedures for performing calibration of the _____ electronic scale that is used to weight the porcelain powder during the repackaging process.
FDA District: Dallas District Office
