Calibration related FDA inspection observations for 2018

Calibration issues in FDA observations

What were the most common calibration related observations for 2018?

We reviewed the report of the 483 FDA forms for the fiscal year 2018 and we present you the most common calibration related observations by industry.

Calibration related observations appeared 384 times in the previous fiscal year. Note that this doesn’t mean that appeared in different forms. Different calibration related citations can appear in the same form.


The most popular citation (61% of the cases) is about lack of or inadequate calibration/ inspection procedures.


The calibration related observation with the most frequency (54% of the total mentions in calibration) is in regards to calibration/ Inspection/ Checking “not performed according to written program designed to assure proper performance.”


The most common observation regarding calibration (34% of the calibration relating issues) is the frequency of verification and record reviews. More particularly they did not review “[some of] their [critical control point monitoring] [corrective action] [calibration] [in-process testing] [end-product testing] records [within one week] [within a reasonable time] after the records were made.”

The second most common calibration related observation (19% of the cases) is about the non-calibration of process monitoring equipment to ensure that it reads accurately.

Vet medicine:

The only calibration related observation is the “failure to calibrate scales and metering devices [upon installation] [at least once a year after installation] [as frequently as necessary] to insure their accuracy.”

How a Calibration Management Software can help you solve those issues?

CompuCal Calibration Management Software was designed with and for customers in regulated industries. The main purpose is to facilitate your calibration workflow management and help you be compliant with the regulations of your industry.

All of the compliance issues highlighted in our research can be avoided using our easy to use automated solutions. If you want to find out more about CompuCal Calibration Software, please contact us. We will be more than happy to help.