The U.S. Food and Drug Administration (FDA) is authorized to perform random inspections and audits, and these inspections can lead to FDA warning letters and FDA Form 483 observations. Quality managers must take several proactive steps to reduce the risk of warning letters, but what exactly should be done, besides the obvious, which is to be in compliance with defined regulations?  

First, let’s define and understand the meaning of warning letters and Form 483 observations.  Warning letters are considered to be informal and advisory by the FDA.  Nevertheless, organizations are expected to voluntarily comply with the law and to take corrective actions.  The FDA Form 483 provides support for the alleged violation and communicates the concerns discovered during the inspection.

Organizations are given an opportunity to voluntarily and promptly respond in writing and include a corrective action plan.  However, if issues highlighted by the FDA are not addressed and communicated in a timely manner, the FDA will initiate an enforcement action, and these actions can include product recalls, fines, penalties, and, of course, your reputation is at stake.

Here are some tips on how to avoid a warning letter and  form 483 observation:

1. Be inspection ready

Have a QMS in place that meets your operational needs and compliance requirements, conduct your own internal audits on a regular basis, identify audit team members and assign tasks, provide a schedule of meetings, identify confidentiality requirements, and involve senior management.  Inform your employees about audits, provide resources needed, and appoint staff to accompany auditors when they do arrive.

1. Clearly Written Standard Operating Procedures

The Standard Operating Procedures (SOPs) need to be clearly and concisely written, but also maintained by getting them modified when necessary. Make sure you document any changes and that only the most recent version is available to your team and to inspectors.  

1. Proper Document Control

An automated document control system provides proper version control of your documents, including SOPs.  Your document control should eliminate the possibility of human errors and provide standardization to your version control, revision history, and approval process.  Establish proper permissions to prevent unauthorized access and changes to your documents.

1. Develop a compliance culture

Make quality and compliance a cornerstone of your culture.  A corporate culture is often driven by the organization’s CEO.  You need your CEO and executive team to be on board, and to understand and communicate the importance of compliance and quality to the entire organization.  One way to ensure senior management involvement is to actively involve them in the initial meeting of an audit, during the audit process, and in the final meeting.  Make sure to keep senior management involved with all subsequent communications with the FDA.

1. Correct observations real-time

Take every effort possible to correct observations while the FDA investigator is still onsite and express that remaining issues are in the process of being addressed, ideally with a stated timeline.  It’s important to communicate these changes or planned changes before or during a close-out meeting, and before the FDA inspection report is completed. Remain professional, provide proof whenever possible, and keep copies of signed-off documents.

1. A hyper-adaptive Quality Management Software

QMS software has evolved from customizable solutions that are typically expensive, time consuming, and with limited configurability capabilities to quality automation software that empower users with tremendous flexibility and at a lower total cost of ownership.  A modern and hyper-adaptive quality automation solution will ensure compliance today and into the future as you can easily address new business and regulatory changes.

If you want to own your own quality and compliance experience, learn more about Intellect’s comprehensive, integrated and hyper-adaptive eQMS software suite and automation platform.

For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.

Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

Things change very fast in the world of mobile apps. Besides the mobile phone manufacturers adding better cameras, processors, accelerometers, and gyroscopes; mobile app developers are following those upgrades up with new and improved apps. When talking about mobile medical apps, you probably wondered if the FDA regulates them. The answer has been changing, and we will present some of the latest rules brought by the FDA to make the picture somewhat more transparent.

Groups of Apps Regulated by the FDA

Before you conduct a regulatory assessment, you should determine whether your mobile app is affected by FDA's regulations. The FDA has been evident in their mobile medical app guidance that they intend to use a risk-based approach when applying their rules. Mobile medical apps that could pose a risk to a patient’s safety or health are the only ones the FDA regulates. There are four possible groups of apps, following the FDA’s way of sorting them:

1. The app is not a medical device,
2. Even if it is a medical device, the FDA has said that they will not regulate it,
3. The FDA will regulate because they said that it is an app, and
4. None of the above.

Apps that fall into groups 1 and two are not regulated by the FDA, while apps from the fourth group are those without analogs in any known examples. Apps from the group 4 are likely to be controlled. It is explained in the FDA’s “Guidance for Industry and Food & Drug Administration Staff” guidance document.

More Challenges with Proving FDA Compliance

The surge of mobile healthcare apps is the surge behind FDA’s regulatory updates and changes in medical app development. According to the Mobile Medical Applications Guidance for Industry and Food & Drug Administration Staff guidance, a medical app is considered to be an app that works as an accessory to transform a mobile medical platform for a form of medical use or augment, supplement, or support an existing medical device. To ensure the effectiveness and safety of medical apps, the FDA will use the same risk-based approach that it uses for other medical devices.

The Emergence of the De Novo Pathway Trend

PMA (Premarket Approval and 510(k) pathways for putting a product on the market have been more popular than De Novo pathway, but this is changing. It is happening because the FDA is streamlining the application process without requiring a 510(k) anymore. What De Novo method provides is a way to classify new medical devices as Class I or II when there’s no predicate device. If a person believes that their medical device is appropriate for classification into these two Classes, they can submit a de novo request without preceding NSE and 510(k). The De Novo pathway is highly risk-based, which means that you can get a product on the market without a lengthy premarket approval application (PMA.) It is only if your new technology isn’t considered high risk and you’re able to demonstrate how all known risks can be mitigated.

New and innovative ways for health improvement and better health care delivery are being opened with the widespread use and adoption of mobile technologies. The FDA is there to encourage mobile medical app development and has a responsibility to oversee their effectiveness and safety. If you’re conducting a digital transformation to be FDA compliant with all new regulations and laws, involve your compliance team to ensure alignment from the beginning.