Category: Blog

For companies operating in FDA-regulated industries—such as pharmaceuticals, medical devices, food manufacturing, and biotechnology—FDA inspections are an inevitable and crucial part of maintaining compliance. Understanding the inspection process and preparing adequately can make a significant difference in ensuring a smooth experience and maintaining compliance with FDA regulations.

 

Why Does the FDA Conduct Inspections?

The FDA (Food and Drug Administration) conducts inspections to ensure that companies manufacture high quality products and comply with federal regulations regarding the safety, efficacy, quality and labeling of their products. Inspections serve to verify that manufacturing facilities follow Good Manufacturing Practices (GMPs), adhere to safety guidelines, and produce products that meet established standards. The legal authority for inspections is outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 U.S.C. §374.

 

Types of FDA Inspections

FDA inspections can fall into several categories, including:

  1. Pre-Approval Inspections (PAI): Conducted before the FDA grants approval for a new product. These inspections verify the accuracy of the information submitted in regulatory applications (21 CFR Part 314.125 for drugs, 21 CFR Part 814.42 for medical devices).

  2. Routine Surveillance Inspections: Periodic inspections to ensure ongoing compliance with regulations. These can be announced or unannounced (21 CFR Part 820 for medical devices, 21 CFR Part 211 for pharmaceuticals).

  3. For-Cause Inspections: Triggered by a specific concern, such as a complaint, adverse event, or suspected regulatory violation (21 CFR Part 7.3(g) outlines recall classifications based on these inspections).

  4. Compliance Follow-Up Inspections: Conducted to verify corrective actions taken in response to previous inspection findings.

 

Sampling During Pharma Inspections

To help ensure that high-quality drugs are sold in the U.S., FDA maintains a comprehensive quality surveillance program. A critical function of this program is testing selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP), an organization that publishes quality monographs for medicines including attributes such as:

  • Identity: is it the right drug as indicated on the label?
  • Assay: how much drug is there and is it consistent with the labeled amount?
  • Impurities: are impurities within established specifications?
  • Dissolution: does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?

FDA quality surveillance program includes multiple tools that complement sampling and testing. These tools include sampling assignment as a result of inspections, evaluation of post-market quality reports, signal detection, and data analysis.

 

What Happens During an FDA Inspection?

While each inspection may vary slightly depending on the industry and facility type, most follow a structured process:

  1. Notice of Inspection: The FDA may or may not provide advance notice of an inspection. When notified, companies should quickly organize relevant personnel and documentation (FDA Form 482 – Notice of Inspection).

  2. Opening Meeting: The FDA investigator(s) will present their credentials and explain the purpose and scope of the inspection.

  3. Facility Walkthrough: Inspectors tour the facility, observe operations, and assess compliance with regulatory requirements.

  4. Document and Record Review: The FDA will request to review various documents, such as standard operating procedures (SOPs), batch records, testing, employee training records, deviation reports, verify data integrity, ALCOA and (21 CFR Part 11 for electronic records and signatures).

  5. Interviews: Inspectors may interview employees at various levels to gauge their understanding of compliance requirements and daily operations.

  6. Observations and Notations: Any potential violations or concerns are noted, typically recorded on FDA Form 483 and issued at the close of an inspection.

  7. Closing Meeting: The inspector provides preliminary feedback and discusses any observations that may require corrective actions.

 

How to Prepare for an FDA Inspection

  1. Maintain a State of Readiness: Always operate as if an inspection could occur at any time.

  2. Train Employees: Ensure that staff members understand regulatory requirements and are prepared to answer questions confidently and accurately.

  3. Conduct Internal Audits: Regular self-inspections can help identify and address potential compliance gaps before an FDA inspection.

  4. Organize Documentation: Maintain well-organized, readily accessible records to streamline the document review process.

  5. Establish an Inspection Plan: Have a clear strategy in place, including designated personnel to guide inspectors, manage documentation requests, and address findings promptly.

 

Post-Inspection Actions

After an FDA inspection, the company may receive an FDA Form 483 if compliance issues were noted. Addressing these findings promptly through corrective and preventive actions (CAPAs) is crucial to demonstrating commitment to compliance. In some cases, the FDA may issue a Warning Letter (21 CFR Part 7.3) if significant violations are found, which requires a more formal response and resolution.

 

Conclusion

An FDA inspection is a critical event that can impact a company’s ability to operate and bring products to market. Proper preparation, adherence to regulatory standards, and a proactive compliance culture can help companies navigate inspections successfully. By staying informed and ready, businesses can not only pass inspections but also strengthen their overall compliance programs and ensure public safety. 

 

Are you prepared for an inspection at your facility? Regulatory Compliance Associates® (RCA) can help your team prepare for inspections, manage inspections or help remediate any adverse findings once the inspection is complete. From developing a training program that suits your professional needs, company goals, and preferred learning style. To working with your leadership to create a response strategy, we have you covered.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

 

Listen to hear RCA’s Director of Regulatory Affairs, Jordan Elder, review the key differences regarding the new Quality Management System Regulation (QMSR) final rule and the current Quality System Regulation (QSR).

 

 

The FDA has recently issued the Quality Management System Regulation (QMSR) final rule, marking a significant update to the longstanding Quality System Regulation (QSR). This change is designed to harmonize medical device quality system requirements with the globally recognized ISO 13485 standard. While the original QSR emphasized product safety and effectiveness through rigorous FDA oversight, the new QMSR aims to reduce regulatory redundancies and streamline compliance, aligning more closely with international standards. This regulatory shift promotes a unified approach to global market access, making it critical for manufacturers to understand and implement the updated requirements.

 

The QMSR rule is set to take effect on February 2, 2026. The FDA has made it clear that enforcement will begin immediately upon implementation, and manufacturers must be fully compliant by this date. Firms that fail to comply with the updated requirements may be subject to 483 observations and warning letters during future FDA inspections.

 

Key Differences Between QSR and QMSR

While the fundamental principles of ensuring device safety and effectiveness remain unchanged, several critical updates distinguish QMSR from its predecessor:

  • Terminology Updates: The QMSR aligns with ISO 13485 terminology, replacing FDA-specific terms used in QSR. For example:
    • Design History File (DHF) becomes Design and Development File
    • Design Master Record (DMR) transitions to Medical Device File
    • Device History Record (DHR) aligns with ISO-equivalent documentation
  • Risk Management Integration: The previous QSR addressed risk management implicitly through various regulatory requirements. The new QMSR explicitly incorporates risk management throughout the device lifecycle, aligning with ISO 14971. While compliance with ISO 14971 is not mandatory, manufacturers must now adopt a proactive and systematic approach to risk assessment and mitigation.
  • Enhanced Design Controls: The QMSR refines design control processes by fully integrating ISO 13485’s design and development requirements. Where the QSR set specific design control mandates, the QMSR ensures manufacturers adhere to globally recognized best practices.
  • Stronger Supplier Management Requirements: Under QMSR, manufacturers must establish quality agreements and ensure supplier compliance with regulatory requirements. This added emphasis on supplier management reflects an industry-wide shift toward accountability throughout the supply chain.
  • Updated Labeling and Packaging Controls: While QMSR retains the labeling and packaging control requirements from QSR, it places a greater emphasis on verification and inspection processes to enhance quality assurance and reduce compliance risks.

 

What This Means for Manufactures

To ensure seamless compliance with QMSR, manufacturers must take the following proactive steps:

  • Revise Quality Documentation: Update quality manuals, procedures, and records to reflect the new terminology and requirements.
  • Personnel Training: Educate employees on the new standard and its implications for day-to-day operations.
  • Strengthen Risk Management Processes: Implement systematic risk assessment and mitigation strategies in alignment with the new regulatory framework.
  • Update Supplier Agreements: Review and modify existing supplier agreements to ensure alignment with QMSR requirements.
  • Plan for a Smooth Transition: Manufacturers should initiate internal audits, update compliance strategies, and engage regulatory professionals to facilitate a successful transition before the enforcement date.

The QMSR final rule represents a pivotal shift in regulatory oversight, providing a streamlined, internationally aligned framework for medical device manufacturers. Preparing now will help ensure compliance, avoid regulatory scrutiny, and support continued success in the global market. Manufacturers should act swiftly to integrate these changes into their quality systems and maintain a proactive approach to FDA compliance.

 

How RCA Can Help

At Regulatory Compliance Associates® (RCA), we specialize in guiding manufacturers through regulatory changes. Our expert team can help your organization transition to the new QMSR by conducting comprehensive GAP assessments, developing a tailored remediation strategy, and assisting with implementation as needed. Ensuring compliance with evolving FDA regulations is crucial, and RCA is here to support your team every step of the way.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected]

The FDA is cracking down on labeling for drug products that will require companies to reevaluate and make changes to new and existing products if they wish to stay in compliance. To ensure companies can continue production without slowdowns, it is important to understand what changes are being implemented and how they will affect your products.

 

Greater Transparency in NDA and ANDA Labeling

In April 2024, the FDA released a draft guidance aimed at improving transparency in drug labeling, particularly for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), which cover generic drugs. Generic drug labeling must contain information to show that the proposed labeling is the same as that for the Reference Listed Drug (RLD), with certain permissible differences. Under 21 CFR 314.50, an NDA must contain a list of all components used in the manufacture of the drug product.  However, historically, there have been several instances whereby the NDA did not disclose all of its ingredients in the labeling,   leading to complications in the regulatory approval process for generic versions. This lack of transparency created delays and regulatory hurdles for ANDAs that relied on accurate ingredient information from their RLD.

 

Moving forward, the FDA is advocating for clearer and more comprehensive ingredient disclosures on NDA and ANDA labels. For example, labeling for non-oral drug products may need to contain the names of all inactive ingredients with limited exceptions.  This shift is intended to eliminate unnecessary review delays and improve the efficiency of ANDA approvals. While the exact compliance strategies remain unclear, the draft guidance from April 2024 is expected to shape regulatory expectations well into 2025 and beyond once the guidance becomes finalized.

 

This change marks a significant step toward improving the drug approval process. Greater transparency in ingredient listings will not only help generic drug manufacturers but also ensure that healthcare providers and consumers have access to complete information about their medications. The push for increased clarity aligns with broader FDA efforts to enhance drug safety and efficacy.

 

New Labeling Rules for OTC Drugs

Another critical update in drug labeling comes with the final rule for non-prescription (over-the-counter, or OTC) drugs under the Additional Condition of Nonprescription Use (ACNU) framework. Published in December 2024, this rule introduces new labeling requirements for certain OTC products to enhance consumer safety and regulatory oversight.

 

Under the ACNU framework, some OTC drugs will require additional steps before consumers can access them. These measures may include visiting the manufacturer’s website or completing a brief manufacture’s to determine whether the product is suitable for individual use. This regulatory approach seeks to strike a balance between expanding consumer access to safe and effective nonprescription medications while ensuring that people use them appropriately.

 

The implementation of this rule could significantly impact both consumers and pharmaceutical companies. On one hand, it enhances safety measures by ensuring that individuals receive proper guidance before using certain OTC drugs. On the other hand, companies will need to update their packaging, labeling and digital platforms to comply with the new requirements. Consumers may also need to adapt to these changes by engaging with manufacturers’ resources before purchasing certain OTC products. The final rule is intended to increase options for consumer access to appropriate, safe, and effective drug products, which could improve public health.

 

What to Expect

These labeling and transparency initiatives will likely play a major role in shaping the pharmaceutical landscape in the future. The FDA’s push for improved ingredient disclosure in NDAs and ANDAs is expected to streamline generic drug approvals and foster greater trust in drug labeling. Meanwhile, the ACNU framework will redefine how consumers interact with select OTC medications, prioritizing informed decision-making and responsible use.

 

Stakeholders, including drug manufacturers, healthcare providers, and consumers, should stay informed about these evolving regulations to ensure compliance and safe medication practices. As the FDA continues refining its policies, further clarifications and potential updates may emerge, reinforcing the agency’s commitment to transparency and consumer safety in the pharmaceutical industry.

 

Preparing for These Changes

For companies looking to stay ahead of these regulatory updates and maintain seamless approvals and production, it is essential to assess current processes and identify gaps in compliance with the new FDA guidelines. Engaging with third-party auditors with relevant expertise can help pinpoint deficiencies and develop a robust implementation strategy, ensuring compliance from the outset.

 

At RCA, we leverage our extensive network of industry experts, including former FDA consultants and leading auditors, to provide comprehensive support. Whether identifying and addressing compliance gaps or designing entirely new processes for emerging products, our team ensures a seamless transition to meet evolving regulatory expectations. Let us help you identify any gaps and help you form a clear strategy that will keep your drug labels in compliance today.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

What is a pre-determined change control plan (PCCP)?

The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after they are authorized. The agency introduced a new regulatory framework called pre-determined change control plans (PCCPs), which allows certain post-market changes to devices using AI or machine learning. PCCPs were first mentioned in a 2019 discussion paper, and the FDA has since issued draft and final guidance on them.

 

PCCP Required Information

This final guidance outlines the required information for PCCPs, which includes;

  • Description of Modifications – The specifications for the characteristics and performance of the planned modifications to the device;
  • Modification Protocol – The associated verification and validation testing activities that will support the planned modifications and acceptance criteria to assure the device remains safe and effective across the intended use populations
  • Impact Assessment – The assessment of the benefits and risks of implementing a PCCP, as well as the plan for risk mitigation.

Need help establishing a PCCP for your medical device?

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Manufacturers can propose updates to AI models, such as re-training to improve accuracy, without needing new submissions, as long as the changes stay within the device’s intended use. However, significant modifications outside the scope of the PCCP, like altering a device’s function or user base, would require new FDA submissions.

 

How do you establish a pre-determined change control plans (PCCPs) for my medical device?

Premarket authorization for AI-enabled devices with a PCCP must be established through the PMA pathway, 510(k) pathway, or De Novo pathway as a PCCP must be reviewed and established as part of a marketing authorization.

 

Follow the link to learn more about RCA’s Medical Device Product Approval Support and Submission Services.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

 

 

In this soundbite from RCA Radio, Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), provides examples of how different size companies leverage the stage of business they’re in to accelerate development with outsourced staff.

 

Start ups vs Large Companies

 

Using Staff augmentation to bring in SMEs gives companies the ability to scale up and scale down quickly without taking away people from other projects.

Start-ups are typically not ready to bring on a full-time employee. In cases like these, we can bring in a subject matter expert (SME) that can help work through any regulatory, compliance, or quality problem and assist on an as-needed base.

 

Larger companies typically need help when they are performing a project such as adding a new manufacturing line into a facility. They don’t do this all of the time and only need the extra resources for this particular project. In cases like these, we will put together a team with the right skillsets that can complete the particular project. Once completed, RCA perform a hand-off with the client, and our team steps away from the project. 

 


Listen to the full episode “Outsourcing and Staff Augmentation” now!


 

All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA has consultants that develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.

 

Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. These companies turn to outsourcing to manage operations and tactical skills, and also help adopt best practices.

 

Successful execution comes through project monitoring, issue resolution, and risk management of the process through clear leadership. RCA’s team of experienced project management professionals organize and manage resources to ensure that projects are completed successfully, on time, and within budget.

 

RCA Outsourcing Services

 

Project Management

outsourced staffTo be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently.

 

Our outsourced staff capabilities for project management capabilities include:

 

  • On-site Project Leadership or Project Management Support
  • Design and Implementation of a Project Management Office
  • FDA Workshops
  • Project Assessment, Remediation, and Follow-up
  • Advanced Schedule Optimization and Management
  • Development and Implementation of Compliant Methods
    • Risk Management
    • Issues Resolution and Decision Tracking
    • Change Management
    • Performance Measurement and Tracking
  • Tool Selection for Program Portfolio and Resource Management

 

Staff Augmentation

Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add experienced professionals to your staff for a short- or long-term project through our medical device staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:

 

  • Quality Assurance
  • Regulatory Affairs
  • Validation
  • Operations
  • Product Development

 

Consulting Support

Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.

 

Advantages of Outsourcing

 

When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. RCA’s quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution, and implement that solution for the utmost success in your project’s completion.

 

Our goal is to help you get your projects to completion on time and on budget — all while outsourced staff keeps superior quality at the forefront of your every task. And with a team of more than 500 pharmaceutical consultants and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.

 

Strategic Outsourcing

 

Medical device manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for outsourced staff and strategic outsourcing services.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

 

Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:

 

 

When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority”.

 


Click to learn about the latest updates to the QMSR File Rule.


 

QMS Harmonization

 

Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.

 

Quality Management System

 

Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.

 

Risk Management

 

The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.

 

These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.

 

ISO Standard

 

With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.

 

Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.

 

ISO 13485:2016

 

ISO 13485:2016 specifies requirements for medical device quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:

 

  • Design controls and development
  • Production and manufacturing
  • Storage and distribution
  • Installation
  • Servicing a medical device
  • Technical support

 

ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.