This is the second blog in series of three that cover our recent experience with FDA inspections 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!), while this one discusses inspection outcomes. The last blog will cover lessons learned.

As a contract design & development and a manufacturing firm, StarFish Medical is subject to multiple audits from registers and clients.  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 the Canadian and the U.S. clients and StarFish each ended up with a form 483 containing 3 observations.

In the early fall of 2015, StarFish and the Canadian client were more or less operating under red alert. Once you know that the FDA is coming you can’t ignore it, so we had daily in-house and joint meetings  to make sure we were covering all aspects of the inspection.

I can proudly say that we handled our inspection the StarFish way: ‘Keep Calm and Carry On.’ However we were concerned whether our records would pass scrutiny of an FDA inspection.  Also, I questioned if early notification was a blessing or a curse. Our Canadian client and StarFish both spent a lot of time getting ready for the inspection, while our US client didn’t have that option due to the short notice they received. In the end we all received 3 observations.

Don’t get me wrong. If we get another FDA notification, I will put in all efforts to make sure every stone is turned and all records supporting products are thoroughly reviewed. If any discrepancies are found, they will be corrected prior to the inspection.

In any case, the inspections went smoothly at all three sites.  As I mentioned in part one, the tone of the inspection was different at each location.

Our Canadian client had to defend a lot of the decisions that they made. In particular there was a lengthy discussion whether a new 510(K) was supposed to be submitted for changes on their device along with justification for specification changes that modified the performance of the device.  The same investigator was friendlier at our site and there were no tough discussions. In my opinion, our staging of the inspection really helped him go through the files more quickly. For example, when we had to wait for data we filled the gaps chatting West Coast style– relaxed and pleasant.

At our US client’s site the FDA investigator was “down to businesses”– in and out on time. As soon as he handed them Form 483 he left the facility. Their observations were related to root cause analysis of customer complaints not being thorough enough in two instances, a training procedure not clear on training needs, and incoming inspection for all received products and services. The investigator also paid a lot of attention to control of vendors and overall record keeping. You’ve heard it before, “If it isn’t documented, it didn’t happen!”

At the StarFish site our FDA investigator spent a lot of time reviewing CAPA, NCR, RMA and ECR/ECO records. He paid particular attention to the description of issues and how they were resolved.  I was pleased that most of the records were very clear. We trained our personnel to tell a short story so that the record would be self-standing and not need additional explanation.

At both Canadian sites, FDA investigators thoroughly examined critical supplier controls.  Our first observation was related to supply chain. As it usually happens, a supplier that was providing an off-the-shelf part changed specification and didn’t informed us of the change. This occurred despite each PO from us clearly stated that we require the supplier to notify us of any changes in product or service. Both our client and StarFish received a Form 483 observation regarding supplier controls and we had to revise applicable procedures and establish more formal supplier agreements. Yes, they now required handwritten signatures. In general, people pay more attention when you ask them to sign a document.  We had to retrain personnel and implement a procedure that required us to sign new supplier agreements with all critical suppliers.

Our second observation was linked to the original client site finding regarding specifications.  Our client did not provide clear acceptance criteria for one of the calibration steps. We had to quarantine and NCR all products, revise applicable work instructions and calibration procedures, and retrain all personnel before we could continue production and shipping.

Our third observation was due to an oversight on our part. As a contract manufacturer, we track product related CAPAs via Non-conforming reports (NCR) or Returned Materials Authorizations (RMA) forms or Engineering Change Requests (ECR). All these forms record the root cause and corrective action and whether the issue could adversely affect a finished device. However, our CAPA procedure did not require that we inform our client (who is responsible for reporting trending) of all the issues. We had to revise CAPA procedure, provide training, provide a current list of all product issues to the client and set up a reporting system for periodic transfer of all product-related issues to the manufacturer.

Since we had to coordinate with the client, we sent our response in two parts – one just before Christmas and the other at the beginning of February. The total size of our response for three observations was 250 pages! We estimated that we spent around $50,000 in labor- not cheap. We are still waiting for Establishment Inspection Report from the FDA. Meanwhile, we are reviewing notes from the inspection and addressing any discussion points as they will be inspected the next time the FDA visits us.