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US FDA GMP Audits to QSR 21 CFR Part 820 for Medical Device and IVD Companies

The US Food and Drug Administration (FDA) requires manufacturers to implement quality systems in accordance with the Quality System Regulation (QSR) per 21 CFR Part 820, formerly known as Good Manufacturing Practice (GMP). Manufacturers, specification developers, contract manufacturers, relabelers/reprocessors, and even some distributors must implement a quality system compliant with the QSR.

Medical device and IVD manufacturers must conduct internal audits of their quality management systems in accordance with the Quality System Regulation (QSR). Failure to conduct an internal audit can result in product quality issues, lack of process improvements, or regulatory compliance issues. Emergo can perform independent internal compliance audits on behalf of clients to determine quality system compliance, particularly for clients lacking the resources or experience to perform their own audits.

Our US FDA QSR auditing services include:

  • Gap analysis audit – Through this audit we will determine your current level of compliance with FDA regulation 21 CFR Part 820. The gap analysis can be conducted at any time on the quality system to identify deficient areas.
  • Full or partial internal QSR audit – FDA regulations require manufacturers to conduct regular internal audits of their quality management systems. Emergo provides internal auditing services which allow for an independent review of your full quality system. We can also conduct specific QSR process audits in which we focus on specific areas of the quality system where you suspect non-compliance occurs or has occurred, or focus on areas where conflicts of interest make an outside, independent GMP audit desirable.
  • Supplier audit - As part of your full or partial QMS audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operation. We can conduct supplier audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable standards and regulations.
  • FDA pre-inspection audit – We can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. Emergo can assist you in identifying any problem areas of your quality system prior to an FDA inspection. This type of FDA  audit is similar to a gap audit, but we focus on any areas that may be reviewed more intently by an FDA Investigator, e.g. complaint handling, design control, corrective action, manufacturing processes, special processes, etc.
  • FDA QSR mock audit – We can also perform a QSR audit that would mimic an FDA inspection to help the facility prepare for an actual FDA inspection. This type of audit can be done without the knowledge of the entire organization or provided as independent assessment of readiness without company personnel being aware. The FDA QSR mock audits are performed using the FDA's Quality System Inspection Technique (QSIT) to prepare an organization for an actual FDA inspection.

Please contact us for more information on US FDA QSR auditing.

Ask us for detailed information about USA FDA 21 CFR 820 auditing services.

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Frequently Asked Questions

Do I have to implement a quality system for a Class I device?

 It depends on the requirements of the FDA classification regulation/product code.

Is ISO 13485 sufficient?

The FDA does not recognize ISO 13485 as being in compliance with FDA QSR (21 CFR part 820). Furthermore, ISO 13485 certifications are not equivalent to FDA QSR compliance.

When will FDA inspect me?

The FDA does not have a time table on when you will be inspected. They can inspect you at any time with little notice. If you manufacture higher risk devices, you are more likely to be inspected.

What happens if I get inspected and it does not go well?

If you get inspected by the FDA, and they find many deficiencies with your quality system, they may issue a Form 483 Notice of Inspectional Observations. You will have a specific period of time to address the problems noted by the inspector.