This is the third blog in series of three that cover our recent experience with FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing. The first blog outlined our inspection preparation strategies (very different for each one!), the second discussed inspection outcomes, and this blog will cover lessons learned.

The FDA inspections are over, our responses are submitted to the FDA and we are all waiting for Establishment Inspection Reports. Our preparations for the inspections and good record keeping ensured that none of the facilities got a warning letter. A warning letter is not the end of the world (providing that you send adequate response to all of the FDA observations), but it is definitely something that every QA professional tries to avoid. For that reason, reviewing lessons learned after each inspection is critical for the success of future FDA visits. You want to close all the gaps and ensure you don’t have repeated finding(s).

Here are highlights of what we learned from these 3 inspections:

If it isn’t documented, it didn’t happen!

An opening presentation is not a sales or marketing pitch. It must be brief and to the point covering what your company does and how you are organized.

Introduce your team and their qualifications at the opening meeting.

Provide sufficient background about the device(s.)

It is critical to assign scribes to keep detailed notes including context of requests for particular records. These notes will be crucial for your response to the FDA. Likewise, keep a copy of all evidence that the FDA Investigator takes from the inspection.

Be precise and directly answer all questions from the auditor. Excessive talking will get you in trouble.

At the closing meeting (or before) it is important to clarify what an adequate response should include for each observation.

Consider each response before offering it!

You will have issue(s) somewhere in record keeping. Train, train and train personnel again. Don’t let inadequately documented records stay uncorrected. Write it right the first time!

Write clear summaries – particularly of unexpected failure results in reports/forms.

Each Record should tell a story, however be thoughtful of wording used. Anything that uses inflammatory language will be scrutinized by FDA. Avoid words and phrases like: sharp edge, known bug, and ‘adverse event on patient’ when in fact a Doctor was using an engineering prototype on pig corpse to assess usability.

Implement naming conventions for the Design History File (DHF).

Ensure traceability of actions and actions completed. Keep records of important email and phone communications.

Make sure your training needs are clearly stated and supported by training records.

Detailed, accurate, and CONSISTENT specifications are important!

Don’t take the term “Critical Components” lightly.

Double check your supplier controls. You must prove you have control of your vendors e. documented evaluation and approval and controlled documents.