The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

QUALITY & COMPLIANCE03.5.2019 Robert Fenton

In 2017, the FDA issued 218 more warning letters for 21 CFR 820 than they did the previous year. The 21 CFR 820 regulation, which the FDA uses to monitor the design, manufacturing, packaging, labeling, storage, installation, and servicing for products, ensures that companies create high-quality materials.

For a medical device, drug, bioresearch, or biologics company, this means there’s not enough focus on quality management. Compliance does not need to be incredibly challenging. With the right tools and systems, your organization can easily prevent a lot of potential noncompliance errors.

The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

Thankfully, there are a lot of common errors that occur in compliance. These issues can shed light on critical gaps in product development, processes, and software. By looking at the most frequent 483 letters sent out by the FDA in 2017, you can audit your operations and prioritize your efforts to prevent noncompliance.


1. CAPA – 21 CFR 820.100(a)

400 warnings in 2017

The majority of FDA 21 CFR 820 warnings from 2017 were for Corrective and Preventive Actions or CAPA. CAPA is the regulation that every manufacturer creates and maintains procedures for corrective and preventive action. Under this regulation, manufacturers must have processes in place to deal with non-conforming products, including the ability to track files and document compliance. According to the FDA, these processes also need to be monitored by a formally designated unit.

In 2017, 400 483 letters were sent by the FDA for CAPA noncompliance. These issues can indicate that teams struggle with communication, record organization, and consistent processes. However, CAPA compliance can easily be monitored and managed using an eQMS, or electronic quality management software. A majority of eQMS solutions will have features for document control, file organization, reporting, and collaboration.

2. Complaint Procedures – 21 CFR 820.198(a)

269 warnings in 2017

The second highest number of FDA 21 CFR 820 warnings were for Complaint Procedures, which are written complaint handling procedures to handle and respond to any challenges quickly and consistently. These complaint handling procedures can include actions such as:

  • Summary of the complaint that includes the situation, address, phone number, and other relevant notes about the event.
  • The complaint product, as well as the specific device history record, model, and serial number for that product.
  • The amount of time until the product failed, as well as context as to whether or not the product failed within the warranty period.

All of these regulations are critical to avoiding a 483 letter from the FDA. With the right system in place, teams can adequately document and manage complaint handling procedures from start to finish.

3. Purchasing Controls – 21 CFR 820.50

138 warnings in 2017

The FDA requires purchasing controls, so companies build compliant products that fulfill and conform to specified requirements. To adhere to purchasing controls, a company’s product development process must include a strategic evaluation of contractors, consultants, and suppliers. The assessments will help manufacturers hire the best partners, that are capable of compliance.

The FDA also requires companies to create contracts with potential partners, where they record and document any quality requirements before build. Your team can use these contracts to show the pre-established agreement in the instance of noncompliance.

4. Process Validation – 21 CFR 820.75(a)

137 warnings in 2017

To effectively support the manufacturing process lifecycle, the FDA recommends implementing concepts and systems including modern development concepts, quality risk management, and quality systems. These concepts make sure that manufacturers follow best practices for manufacturing human and animal drug and biological products.

This process validation is critical to help companies improve their systems and sustain growth while remaining compliant with manufacturing regulations.

5. Nonconforming Product – 21 CFR 820.90(a)

127 warnings in 2017

As the FDA states within 21 CFR 820.90(a):

“Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements….” –

Basically, although nonconformance can occur, it’s important that organizations learn and improve from their mistakes. These mistakes can happen during product development and impact the final product.

To prevent future issues, the company must address various aspects of their process, such as identification, documentation, evaluation, segregation, and disposition. Without an understanding of your current process, it will be challenging to address and resolve these issues.

6. Documentation – 21 CFR 820.100(b)

115 warnings in 2017

Consistent documentation is critical to adhering to FDA 21 CFR 820 noncompliance. Often, this requires the use of a document control system and process, which gives companies the ability to track and manage reports, contact records, and other critical information. The FDA requires this documentation in the instance of an audit.

How To Respond to a 483 Letter for 21 CFR 820 Noncompliance

While the FDA does not want to get in the way of your product development, they need to make sure that companies create compliant materials. If you receive a 483 letter, it can be an opportunity for growth and positive change, shining a light on the need for more substantial quality management processes.

You can use our free ebook, 10 Considerations for Responding to an FDA 483 Letter, to guide you as you navigate responding to a 483 letter.