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Ignoring these 7 Signs Can Get You FDA Warning Letter 

01 Aug 2023
Ignoring these 7 signs  can get you FDA warning letter

Qualityze Podcast : Ignoring these 7 Signs Can Get You FDA Warning Letter

A Warning Letter (or Form-483) of Inspectional Observations from the FDA is a nightmare for regulated businesses. Receiving a list of deficiencies can feel like a heavy blow to a quality assurance system in controlled food, agriculture, and pharmaceutical industries. Even worse, the FDA appears to be stepping up its enforcement mandate after adding enforcement staff in 2009 and changing the response time from 15 days to 14 days in September 2009. 

Consumer goods are regulated by the Food and Drug Administration (FDA). A wide variety of these products can be found in the marketplace, such as food, beverages, cosmetics, personal care products, nutraceuticals, dietary supplements, pharmaceuticals, and medical devices. The FDA will send a warning letter to manufacturers who are found to violate compliance. 

The FDA warning letters outline the primary violations observed by inspectors but may also contain information about other errors committed by the manufacturer. FDA letters outline the nature of violations and instruct the recipient to correct all infractions, even if they are not listed. Manufacturers are responsible for reviewing and addressing possible noncompliances. Those who fail to do so may have their product seized by law enforcement personnel or face charges for manufacturing adulterated products. 

Ignoring these 7 Signs Can Get You FDA Warning Letter  

Here are seven warning signs that can get you FDA warning letter: 

Non-compliance with FDA Good Manufacturing Practices

The FDA regulates manufacturers in multiple industries vertically through Good Manufacturing Practices (GMPs). A current good manufacturing practice (CGMP) represents an industry’s current best practice standards. Though these practices may evolve at any time, several key points remain vital throughout every iteration. 

GMP requires every manufacturer to implement and maintain a production and processing control system, which is an essential obligation under most versions of this regulation. Most GMP guidelines address establishing or not establishing such procedures in some way. Consequently, many violations stem from unfulfilled production and processing control requirements or their inadequate implementation at a certain point in the process. 

A violation of the FDA’s labeling, branding, and classification laws 

It is the FDA’s responsibility to identify products in a manner considered legally adequate by the agency, and failure to do so can result in severe consequences. Accordingly, pharmaceutical, medical device, and cosmetic manufacturers are heavily scrutinized for how their end products are marketed and sold in the US. This regulation also covers how ingredients are labeled on products and how the FDA recognizes their inclusion. 

In addition, the Food, Drug, and Cosmetic Act (FD&C Act) and later legislation segmented consumable products more precisely according to the FDA’s strict definitions. Some marketing claims or ingredients can lead to a product being labeled mislabeled. Its classification will either be lost or redefined entirely, resulting in a change in the marketing of the product. 

A violation of documentation & recordkeeping laws 

Records management regulations are partly part of established GMP requirements for many industries, but archiving and maintaining processing information is an essential component of compliance. It is important to document processes to ensure compliance as well as to track instances of noncompliance back to their origins. Several regulatory tasks require this information. 

Related Article: A Brief Guide to Federal GMPs for Dietary Supplements

Documentation regulations for FDA-regulated processing actions require written instructions and audit trails to demonstrate the completion of these tasks. To ensure complete visibility across the end-to-end supply chain, these records contain a roadmap for before and after production practices are implemented and input from users at key processing stages. The FDA can use this data to verify compliance, identify errors, and determine if they have been overlooked if you ignored them. 

The FDA requires documentation of compliance-related processes in nearly all industries, but some sectors have more stringent reporting requirements. For example, those who manufacture medical devices for human use must submit all data regarding their products. In addition, they must submit similar data every time they introduce or change the product, including when it malfunctions. Therefore, data capture and management are essential for maintaining compliance with electronic documentation and reporting regulations. With Enterprise Management, you can access this information and demonstrate compliance with the supply chain. 

An absence of adverse event reporting 

As part of 21 CFR Part 803, manufacturers must report device-related serious injuries, deaths, and malfunctions to the FDA. FDA data suggests that manufacturers tend to underreport these events. In the past decade, FDA has identified over 2,000 medical device establishments with deficiencies in adverse event reporting. In the year before an inspection, companies cited for violations reported three times more than they did the year before. Reviews are necessary to ensure that the right level of reporting is driven by FDA enforcement.  

Where should the line be drawn? 

In this case, there are no clear thresholds or magic numbers. The reporting level depends on the industry’s device type and maturity level. The FDA may look at you more closely if it suspects you are reporting below the industry average. Even though it may not be the only factor in their assessments, it could indicate others.   

The response time to field failures, including voluntary product recalls, is longer

As a precaution against injury, manufacturers commonly recall medical devices voluntarily. FDA reports these under 21 CFR Part 806. Taking longer to correct field issues in the field or issue a recall is another indication to the FDA that there are deeper underlying quality issues.  

Based on data in the report, companies with reporting issues under Part 806 voluntarily recalled 20% more products over the subsequent year. Additionally, they reported recalls eight times more frequently than the industry average following inspections. Since 2009, FDA claims there has been a 50% increase in annual recalls due to this issue.  

Having recurring failures or malfunctioning devices is becoming more common 

A malfunction occurs when a device does not meet the specifications. There is a risk of severe injury associated with some device failures, but not all of them. Various problems could occur, such as malfunctions, alarms, broken components, battery problems, sparks, fires, and shocks. Repeated incidents may not cause injury, but repeated failures can. 

The occurrence of these failures that happen repeatedly or when the trend continues usually indicates a deeper problem. As a result, the FDA is likelier to take action on devices with such track records than others. 

Your responses to FDA observations are slow and unsatisfactory 

During inspections, FDA expects prompt and thorough corrections. However, in most cases, they will issue a warning letter if they do not believe the corrective actions are practical. A record 189 warning letters were published in 2012, representing a more than sevenfold increase from 2007. 

Since late last year, they have provided feedback on corrective action plans and monitored progress by giving feedback to companies. 

FDA gives you a second chance! 

There is growing recognition by the FDA that warning letters do not always resolve issues and improve patient safety. Therefore, collaboration with the violator company seems like a new approach. This resulted in fewer warning letters, but nearly two-thirds of companies must comply with follow-up inspections.  

This category of the company will be scrutinized more closely by the FDA. Therefore, the best corrective action must be taken promptly and effectively.  

Quality is not a priority within your organization 

Lastly, the report points out recent steps taken by the FDA to promote quality and move beyond compliance. In the hidden message, the FDA is watching how you do business and how patient safety is integrated into your strategic goals. As a result, a new expectation exists regarding management responsibility! 

It is fine if your company has a culture of quality, not just routine compliance. However, your organization will likely face more scrutiny from the FDA if you fail to comply with their risk-based targeted approach. 

It monitors malfunctions in medical devices, compliance trends among manufacturers, and public health concerns to take targeted action against manufacturers who pose a high risk to the public. 

Plenty of adverse events, malfunctions, and compliance trends are available to the FDA. Data may not be perfect, but it raises red flags and directs the FDA to prioritize enforcement. 

A robust Post-market Surveillance System like Qualityze can help in monitoring your data and publicly available industry data to identify these signals. You can experience the Qualityze difference by requesting a free demo right now! 

Please contact our customer success team at info@qualityze.com for more information related to our smarter quality solutions, or you can call 1-877-207-8616, and our quality experts will get back to you soon as possible. 



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