CSV FDA Warning Letters : Operational Compliance

Date: 21 December 2009
Link: FDA Warning Letter (New Window)

Observation

19. Automatic, mechanical, or electronic equipment is not routinely calibrated, inspected, or checked according to a written program designed to assure proper performance [21 CFR 211.68(a)]. For instance, the mixer, scales, filling/dispensing machine, water distiller, foil heat sealing machine, drying chamber, and tablet press are not calibrated and inspected in accordance with a written program.

Comment

The regulated company must have a maintenance program including calibration. At Installation Qualification (Verification) assurance should be sought that the maintenance program has been put in place. A check should ensure that the calibration frequency is established and that a mechanism is in place (Maintenance Planning and Reporting System) to ensure that the calibrations are performed and the calibration data recorded.