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FDA observations relating to calibration in warning letters

We analysed the FDA warning letters data from the last five years with the focus on calibration and maintenance issues. According to the results, 4.92% of the letters were related to calibration issues and 11.32% of them were related to maintenance issues.

In most of these cases, the calibration related issues could have been prevented with an automated Calibration Management Software like CompuCal.

FDA observations related to calibration

We reviewed the inspectors’ observations of 2017 as they are provided by the FDA. These are observations that the inspectors have stated on forms 483 and warning letters. For the purpose of the research, we searched for observations that included the word ‘calibration’.

The issues highlighted during these Audit inspections, that resulted in issuance of form 483 and warning letters are related to many different areas but all can be resolved with the right systems in place.

Here are some common FDA observations related to calibration:

  1. Routine calibration of equipment is not performed according to adequate documented procedures.
  2. The calibration of instruments, apparatus, gauges, recording devices is not done.
  3. Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not documented or followed.
  4. Deviations not being reported in a timely manner and in some cases not reported.
  5. No formal procedure in place for calibration execution and deviation management.
  6. Documented calibration / inspection records are not maintained.
  7. Laboratory records do not include complete records of the periodic calibration of laboratory instruments, apparatus, gauges, recording devices.
  8. Calibrations being missed.
  9. Calibration Sheets/Reports are missing.
  10. Calibration procedures do not include specific directions and limits for accuracy and precision or provisions for remedial action.
  11. Hand written reports not legible and incomplete.
  12. Failures being missed through manual error calculations.
  13. There was no review of some of the critical control point monitoring, corrective action, calibration, in-process testing or end-product testing records within one week or within a reasonable time after the records were made. (food sector)
  14. The process monitoring equipment is not calibrated to ensure that it reads accurately. (food sector)


CompuCal is a fully compliant calibration software that can help you to be audit ready and prevent these issues from occurring. Contact us today to discuss your options.

As we mentioned, in most of the cases, the calibration related issues can be prevented with a Calibration Management Software. First of all, thank to a calibration software you avoid problems and mistakes related to hand written reports and manual error calculations. Moreover, you have all the procedures documented and reports generated anytime. To find out more check our article about 10 reasons why you need a calibration management software.