Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program.
FDA inspections can be scary and stressful. Someone is looking at all your records, checking your procedures and testing you. Every answer leads to another question. It is very similar to being deposed by a lawyer. The inspection process has to be like a symphony: there are musicians (company lead) and the audience (the inspector) but there is also the conductor and all the staff behind the curtain. If the oboe player is off or the sound guy messes up, the whole orchestra sounds off. If you are prepared and the Quality System is compliant, the inspector might walk out with no observatons.
But, what happens if everything is not perfect? The inspection could result in a 483 notice and worse the 483 observations could lead to a warning letter. Receiving a 483 notice means FDA inspectors have observed something that may be in violation of the FD&A Act and requires action. You have to understand the observation language (it is not always clear) and know how to answer the root cause of the observation, not just correct the immediate finding.
It is in your best interest to act immediately because the FDA generally requires an adequate response within 15 business days after notification. That response should typically include the following steps:
- Carefully review the FDA observations to fully understand the issues and problems and analyze them.
- Establish a response team that can adequately address and resolve the issues
- Develop a thorough and appropriate response to the FDA that includes a corrective action plan with timelines
- Show a commitment to patient safety and product quality to demonstrate the seriousness with which you approach the issues raised
- Review your FDA response with your entire team to ensure it is accurate, appropriate, and actionable
- Implement it as promised and be able to document that you have followed through with your plan
A warning letter is even more serious, alerting the company that the FDA has, in fact, found regulatory violations that has an impact patient safety. A warning letter requires a quick, stringent remediation program to bring the manufacturer back into compliance. Once a warning letter has been received, the clock is ticking. Remember a warning letter is a public document: all of your competitors and customers will know that you have serious issues with your quality system and possibly your product.
Be prepared before an FDA inspection
To minimize anxiety and maximize efficiency should you become the subject of an FDA inspection, there are several general tips that can help you be prepared:
Conduct periodic internal inspections
Regularly conducting a practice mock inspection will help you stay sharp and boost confidence. Not sure what an inspection might entail? We can conduct internal mock-FDA inspections (or ISO 13485 audits) for you.
Manage documentation efficiently
Virtually every FDA inspection revolves around documentation – Procedures, Complaint records, MDRs, CAPAs, DHF, DHR, changes, product labels, and supplier documents, to name a few. Make sure you have them all in order, compliant and available.
FDA wants to know if the employees know the Quality System. It may not only be the Quality Staff that has to answer questions. FDA will commonly ask operators and engineers questions. Everyone needs to know how to answer the questions.
Keep up with standards and rules
Staying abreast of the regulations that affect you will go a long way in minimizing risk. Everything you need to know is published, it’s just a matter of committing the time and effort to periodically reviewing regulations to make sure you’re in compliance and won’t get caught flatfooted if an inspection comes your way.
Add a regulatory compliance specialist to your team – MEDIcept
We’ve got in-depth, hands-on, face-to-face FDA inspection experience so there’s nothing that surprises us. We’ve been in your shoes, many times, and have effectively dealt with FDA inspectors. And if the worst happens we can help ensure that 483 notices are quickly and efficiently handled to minimize risk, exposure, and delays.
We can assist in creating a response team, develop informed FDA request responses, and provide complete support throughout the inspection and response process. We can conduct a mock FDA inspection prior to an inspection and provide you with a list of action items that can be addressed and corrected so you’re better prepared for the FDA visit.
Our Emergency Regulatory & Compliance Assistance program provides comprehensive inspection support, including:
- FDA inspection
- Inspection response
- Health hazard evaluations
- Medical product recalls
- CAPA plan development, implementation, and effectiveness review
- MDR filings
Why go it alone? Get the FDA inspection help you need from us. We’ve got the experience and expertise to help you weather an inspection or product safety emergency. Just give us a call or drop us an email today for more information.