Failure to 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, as required by 21 CFR 820.72(a). For example, the _____ used to ____ in _____, has not been validated, to assure it is working as intended. In fact, our investigators found that the unit was not cycling from the minimum to maximum temperatures, as required by the _____ procedure. This failure was not detected by your firm.
