6 Tips to avoid 483 letters

Posted by Peter Hargittay on Wed, Nov 28, 2018 @ 02:40 PM

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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.


Tags: 483 Warning Letters, FDA regulations, FDA compliance, FDA, fda standards, Document Control, warning letter

Food Industry: Ensuring Quality and Operational Excellence

Posted by Romeo Elias on Thu, Aug 16, 2018 @ 02:41 PM

 

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Striving for Operational Excellence is nothing new to both leaders and followers in the food industry. Still, given the industry’s unique characteristics, finding a way to accomplish it can be a difficult feat for a company.

Any food industry enterprise often finds itself at the mercy of global commodity markets. Once you account for other difficulties such as high demand variability and low margins, it becomes clear why achieving Operational Excellence is a challenge. However, there are ways to ensure both quality and Operational Excellence in the food industry. Here are the things you should keep in mind:

Optimizing Your Manufacturing Process

You can’t achieve Operational Excellence without having a firm hold on your manufacturing process, and that starts with controlling your data. The only way to optimize the process is through data collection and analysis — the more automated this process is, the better. To this end, do away with paper-based systems and digitize them instead. You’ll feel the positive impact of this change throughout your entire organization. There are plenty of benefits to enjoy, from making it easier to demonstrate compliance with quality standards, to being able to trace your metrics a lot more reliably.

Keeping Up with Compliance Standards

With digitizing your enterprise comes the ability to track your implementation of compliance standards. It is important because it gives you some useful insights into how you can improve the quality of your products. It’s always better to address compliance standards early on, instead of running afoul of them and having to correct course. It keeps customers happy and prevents possible financial consequences.

Becoming Able to Save the Day

In case of an unwanted event related to non-conformance to compliance standards, you need to be able to react quickly. Especially in the food industry, any product can become the victim of a quality issue. It leads to costly recalls and damaged brand reputation. To prevent this, you need to be able to catch compliance issues before they become a huge problem. With automated workflows that can manage compliance issues before they escalate, you can avoid the brunt of the blow.

Learning How You Affect the Environment

Another thing that could become a problem is the sustainability costs. If you wish to have a clear picture of how much your operations cost, you can’t forget to include sustainability costs when measuring your KPI. Once you have the data, you can analyze it to see if it’s possible to improve the efficiency of your manufacturing process by reducing some of the costs. Use sustainability information along with your general production data to truly understand its impact.

Implementing Enterprise Systems

The right tools can be of immense help in your quest to achieve Operational Excellence. Use them to create a lasting foundation for conducting all your processes and improving collaboration while breaking down the silos in your organization. Enterprise systems like ERP and QMS can integrate and synchronize all the systems and methods in your organization to create a single, strong value chain.

Here at Intellect, we have an out of the box eQMS solution that can help you do it. Let go of outdated processes and achieve Operational Excellence by driving success with collected data and automation.

Tags: FDA regulations, food industry, mobile compliance, Compliance, manufacturing

Mobile and FDA Compliance: New Regulations in 2018

Posted by Romeo Elias on Tue, Jun 19, 2018 @ 02:00 PM

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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.

 

Tags: mobile apps, mobile applications, mobile compliance, FDA, FDA compliance, Regulations, FDA regulations, new regulations