FDA 483 Tips #3

Procedures describing the calibration of instruments and apparatus are deficiently written or followed.

Related FDA483/Warning Letter

  1. 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 qualification of all chambers only included mapping studies with (C) empty chambers. The chambers were never challenged by filling the storage space and proceeding with mapping studies. These chambers were (D) observed to be fully loaded. (d)



  1. The SOP should discuss new equipment calibration setup and should document the assigned calibration frequency schedule.
  2. VMP should list history of work performed and upcoming work.
  3. Empty and Full PQ runs, ramping runs, PQ’s should simulate intended processes.
  4. USE photos to document sample and thermocouple placement during validation runs.
    1. If you use a statement in your validation process to leave a space between the product and the wall make sure in normal practice you mark this line on you shelf.

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