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Posts Tagged with Calibration

FDA 483 Tips #4

FDA 483 Tips #4

May 24, 2016

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....

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FDA 483 Tips #3

FDA 483 Tips #3

May 22, 2016

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...

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FDA 483 Tips #2

FDA 483 Tips #2

May 17, 2016

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),...

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