Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter b) The two calibration points evaluated were 0 C and 100 C, thus there was no challenge to the actual range of operation which were mentioned to be C to C....
Posts Tagged with Calibration
FDA 483 Tips #3
Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter d) The (A) calibration program for your stability chambers is deficient in that it does not include specific directions and schedules. You do not (B) perform re-qualification of the stability chambers. The original...
FDA 483 Tips #2
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection Related FDA483/Warning Letter Sub section M. On 06/24/10 a request was made for the last performance qualification for the (B) Walk-In Stability Chamber (25/60),...