A client of mine recently received a FDA Form 483 with multiple inspection observations and they wanted to know how to prioritize their corrective actions. Typically companies will work on corrective actions for each 483 observation in parallel. However, if you receive a 483 observation against your CAPA process, it’s important to address that issue before any of your other inspection observations.

One of the most common 483 observations is specific to corrective and preventive actions (i.e., 21 CFR 820.100). Typically the company has inadequate procedures for verifying and validating effectiveness of corrective actions taken. If this is one of your FDA 483 observations, then you may have a problem with CAPA training or with the design of your CAPA form. If there is no place on the CAPA form to document your effectiveness check, then you might easily forget to perform the verification and validation of effectiveness. Another possibility is that personnel are confused between verification of implementation and the verification of effectiveness.

The FDA will want to see objective evidence of implementing corrective actions whenever possible. If you write your 483 response for other inspection observations first, then the other 483 responses are using the existing procedure or form that the FDA identified as inadequate. If you use your new and improved CAPA procedure and form to document your 483 response, then the FDA will see lots of evidence of your company implementing the revised procedure or form.

Therefore, your first step should always be to implement corrective actions to address an inadequate CAPA process by revising the procedure or the form. Once the procedure or form is updated, then you can use the new process to document the rest of your 483 responses.

I shared more about this issue in my blog that was published this morning;

http://medicaldeviceacademy.com/blog/

If you need help preparing an FDA 483 response, here’s a link for a webinar explaining the 7 steps for responding to an FDA Form 483 inspection observation:

http://medicaldeviceacademy.com/7-steps-respond-fda-483-inspection-observation-webinar/.

source: https://www.linkedin.com/groups/2070960/2070960-6103198324460974083