The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022


    FDA 21 CFR 820 is used by the FDA to set the quality benchmark for the design, manufacturing, packaging, labeling, storage, installation and servicing of US-marketed medical devices.

    Form 483 inspectional observations, issued by the FDA when 21 CFR 820 non-conformities are noted during inspections, are a good window into the areas where medical device companies are most typically struggling with compliance.

    Let's take a look.


    The 6 most common triggers for FDA 21 CFR 820 non-compliance



    1. CAPA processes - 21 CFR 820.100(a)

    193 observations in 2022

    The single-biggest cause of FDA 21 CFR 820 Form 483 observations from 2022 stemmed from Corrective and Preventive Actions or CAPA.

    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 2022, 193 Form 483 observations were issued 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)

    183 observations in 2022

    The second highest number of FDA 21 CFR 820 observations 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.


    3. Process validation - 21 CFR 820.75(a)

    86 observations in 2022

    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.


    4. Purchasing controls - 21 CFR 820.50

    79 observations in 2022

    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.


    5. Nonconforming product procedures - 21 CFR 820.90(a)

    69 observations in 2022

    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….”


    Although non-conformance 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. MDR procedures - 21 CFR 803.17

    62 observations in 2022

    Medical device organizations need to report faults or flaws in their devices quickly and effectively.

    For this, medical device reporting (MDR) procedures are crucial.

    Lack of properly developed, maintained and implemented MDR procedures took our 6th spot on the list of the most common inspectional observations for medical device companies.


    Don't make the same mistakes


    A robust, properly maintained quality management system (QMS) is your ticket to strong FDA 21 CFR 820 compliance and insulation from the risk of Form 483 inspectional observations.

    Consider maximizing the strength, visibility and control of your QMS with medical device quality management software - designed to bring your documentation, training, quality event, supplier and design control management functionality together into a single, cloud-based source of truth.