This is the first blog in series of 3 that will cover StarFish Medical’s recent experience with the FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.

As a contract design & development and a manufacturing firm, StarFish Medical is subject to multiple registers’ audits (NAMES) and client audits.  We are also inspected by the FDA every 2 to 3 years for client medical devices marketed in the US. At the end of 2015 a manufacturing client was inspected by the FDA, then, 3 months later another client was inspected. Both clients and StarFish each ended up with a form 483 containing 3 observations.

These blogs outline our inspection preparation strategies (very different for each one!), inspection outcomes, and lessons learned.

3 different FDA inspection preparation strategies

The first firm inspected is a Canadian-based company. Therefore the announcement of the FDA inspection was received 3 months prior to the inspection.  As soon as we found out that our facility would be inspected by the FDA we notified our US-based clients that they may expect an inspection too.  In case you are not aware, firms in US get very short notice or the FDA may choose to simply knock on their door. In this case our US client got 1 week notification.

Pre-inspection preparation

After receiving notification, our Canadian client hired QA/ RA consultants from Emergo to conduct a mock-up FDA inspection.  We were more prepared. I anticipated an FDA inspection sometime in 2016, so we hired Larry Spears, ex CDRH Director, to inspect StarFish in March 2015. The corrective actions we made as a result of that mock inspection were fundamental to the success of our actual FDA inspection in December 2015.

On the other hand, our US client received very little notice and barely had time to do any preparation beyond making senior personnel available on site. They asked us to send one of our QA/RA specialists to support their QA Manager during inspection.

For 3 months we worked closely with our Canadian client on reviewing product records, making sure all employees were trained on how to handle the inspection and setting up the ‘stage’ for the inspection. We ensured both facilities would leave a good first impression: well organized, tidy work areas with tight record control. We reviewed all product relevant files and closed any gaps:

• Device Master Records (DMR)
• Device History Records (DHR)
• Relevant CAPA
• Product NCR
• Returned Material Authorization (RMA)
• Unit Production Records
• Incoming Inspection Records
• Equipment and jigs
• Vendor Qualification Records
• Certificates of Conformance for critical components
• Distribution records

The inspection experience

When it came to the actual inspection strategy- we again had completely different approaches.  Our Canadian client provided documents and records from their ‘war room’ only upon request and brought in personnel as needed. Opening and closing meetings were limited to only a couple of senior personnel and myself as an observer.

StarFish strategy was completely different. We had all relevant product and facility documents and records set up in our boardroom with all the personnel involved in manufacturing present for the duration of the inspection. At our opening meeting we provided an organization chart, introduced personnel, their qualifications and role at StarFish and clarified involvement with the product that was inspected.  As the inquiries were coming, relevant personnel was providing evidence of the compliance.

Everything that you may have heard in training on “how to handle FDA inspections” we did not do. There was no ‘war room’, no discussions of what to say, and no prescreening of the documents and records. We put into practice our core value: ‘We are open and welcome accountability’. As a result, the tone of our inspection was more friendly and relaxed then at our Canadian client site. The FDA Investigator could see that we were neither trying to hide anything nor delay providing evidence.

In addition, our personnel (~ 25 employees: engineers, production technicians, supply chain professionals, project managers, QA/RA personnel, and Senior Management) got the opportunity to learn firsthand what FDA expectations are – priceless hands on training.  After the closing meeting, we celebrated the successful inspection results, shared refreshments and chatted with the FDA Investigator.

Our US client didn’t have much time to prepare or strategize; they made sure that QA and management were there to support inspection. Luckily, most of their records are electronic and easily retrievable during inspection. The FDA investigator was very formal and somber at all times. He efficiently went through the records and left the facility as soon as the inspection was completed.

Which strategy worked the best?

Establishing a good rapport with the investigator didn’t prevent StarFish from getting 3 observations, but the whole experience was less stressful in the pleasant, cooperative environment.  Our clients received 3 observations each regardless of their level of preparation.

I recommend our approach.  It was based on my experience sitting on the other side of the table as a GLP inspector for Standards Council of Canada (SCC). That experience gave me this insight on how to better handle inspections. Treat auditors and investigators the way you would like to be treated. On both sides of the table, we are all just trying to do our jobs the best we can.