Here are some common FDA observations related to calibration:
- Routine calibration of equipment is not performed by following necessary documented procedures.
- Methodology describing the calibration of instruments, is not being followed.
- Deviations in calibrations not being reported or closed within per time frame.
- No formal procedure for out of calibration and change management.
- Documented calibration / inspection records are not updated.
- Laboratory documents are not having important information and records such as complete records of the periodic calibration.
- Calibrations not done as per schedule.
- Calibration work sheets/Annexure are missing.
- Calibration procedures do not include specific directions and limits for accuracy and precision or provisions for remedial action.
- Several Hand written reports were not readable and insufficient.
- In many calibration manual error calculations were noticed. (updated on 28.09.2020)