Health Canada’s GMP Inspection Trends: Insights for Pharma Compliance

What do Health Canada Drug GMP Inspectors Focus On?

When a Health Canada inspector shows up at your drug manufacturing facility, what are the probable inspection targets? What areas are likely to be focused on, and what are their expectations?

Health Canada: Brief Background

Canada’s drug regulatory agency, Health Canada, requires a drug establishment license (DEL) for a facility to be authorized to conduct manufacturing, packaging, labeling, testing, importing, distribution, or wholesaling of drugs. The agency inspects these sites to verify requirements for good manufacturing practices (GMP) are met before a DEL is issued.

Health Canada’s GMPs are published in its Good manufacturing practices guide for drug products (GUI-0001) and Good manufacturing practices for active pharmaceutical ingredients (GUI-0104).

The Regulatory Operations and Enforcement Branch (ROEB) is responsible for conducting industry inspections of both finished dosage form and active pharmaceutical ingredients (APIs) for domestic manufacturers, packagers, labelers, importers, distributors, wholesalers, and testing facilities. They also inspect foreign manufacturers, packagers, labelers, and testing facilities. Foreign facilities are not issued a DEL but instead are listed on the DEL of a Canadian license holder.

Health Canada: Inspection Process and Results

During a GMP drug inspection, a ROEB inspector notes deviations from the regulations as outlined in GUI-0001 and GUI-0104. At the end of an inspection, Health Canada schedules an exit meeting to present the observations to the establishment, in the form of an inspection exit notice.

This document outlines any observations (deficiencies) noted by the inspector. Subsequent to the exit meeting, the inspector will issue the establishment a copy of the exit notice. After the exit notice is reviewed and finalized by the agency, it becomes an Inspection Report Card.

Health Canada’s Inspection Report Card is a publicly accessible summary of the findings from inspections conducted on establishments involved in activities such as manufacturing, packaging, testing, importing, distributing, and wholesaling drugs and health products.

Each report card provides key details, including the establishment’s name, reference number, inspection date, type of inspection, overall rating (e.g., compliant or non-compliant), a summary of observations noting any deviations from regulatory requirements, and the measures taken by Health Canada in response to the findings.

These report cards are part of the Drug and Health Products Inspections Database (DHPID), which supports open government and regulatory transparency by offering up-to-date information on the compliance status of health product establishments.

Observations are expected to be addressed by the company, usually in the form of a corrective action and preventive action (CAPA) plan that includes target dates for completion.

Health Canada’s Inspection Report Card and the U.S. FDA’s Form 483 serve similar functions in regulatory oversight but differ in their scope, purpose, and public availability.

Health Canada’s Inspection Report Card

• A summary report of an inspection conducted at an establishment involved in drug manufacturing, testing, importing, or distribution.
• Provides an overall compliance rating (e.g., compliant or non-compliant).
• Includes key observations from the inspection but does not detail every individual deficiency.
• Publicly available through Health Canada’s Drug and Health Products Inspections Database.
• Used to increase transparency regarding regulatory compliance within Canada’s pharmaceutical industry.

FDA Form 483

• A detailed list of specific observations issued when an FDA investigator identifies potential violations of Good Manufacturing Practices (GMPs) or other regulatory requirements during an inspection.
• Form 483 is not a final determination of non-compliance but serves as a notification to the company that corrective actions may be necessary.
• It is issued directly to the firm at the conclusion of the inspection.
• While not automatically public, Form 483s can be obtained through Freedom of Information Act (FOIA) requests, and high-profile cases often become publicly available.

Figure 1 | Differences in Health Canada’s Inspection Report Card and the U.S. FDA’s Form 483

Bottom Line for Quality & Regulatory Leaders

• Health Canada’s Inspection Report Card is a high-level compliance summary used for transparency, while FDA’s Form 483 is a detailed notification of possible GMP violations requiring corrective actions.
• A non-compliant rating on an Inspection Report Card can trigger regulatory enforcement actions, just as Form 483 observations can escalate to a Warning Letter or other FDA enforcement actions if not addressed adequately.
• Monitoring both Health Canada’s and FDA’s findings is crucial for global pharmaceutical companies to maintain compliance and mitigate regulatory risks across markets.

Mining the Results

The Redica Systems database currently contains approximately 2,575 Health Canada inspection report cards spanning January 2012 to January 2025 that taken together include more than 15,000 individual observations.

Observations by ROEB inspectors include a reference to the GMP section where deficiencies were noted. For example:

C.02.015 – Quality control department: The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

So, how often are each of the areas cited in inspections? The frequency of the observations shows us where deficiencies are being found (Figure 2).

Figure 2 | Distribution of Health Canada Inspection Findings

Note that the largest deficiency area is in Quality Control – a broad category that includes all quality unit responsibilities for internal processes and external third-party partners, followed by Manufacturing Control, which includes the entire manufacturing train in the inspected plant beginning with raw materials.

How does this compare to U.S. FDA inspection findings? Here is a graphic representation of the Redica Systems data set for FDA 483s between 2000 and 2022 with more than 300,000 sites and 940,000 inspections. It is organized by the FDA six quality systems (Figure 3).

Figure 3 | FDA 483 Observations by Quality System (2000-2022)

In this case, the Production System has the most observations with Quality Control second. Because Health Canada and FDA use different classifications, comparing these focus areas is problematic.

Closer inspection shows that some Health Canada GUI-0001 sections map directly to the FDA Quality Systems while others do not (Figure 4).

Figure 4 | Some Health Canada Topics Combine FDA Quality System Topics

At Redica Systems we have developed labeling models for FDA 483s and warning letters that can label inspection findings by quality system and subsystem often down to three levels.

The example used above for Health Canada, “The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.” would map to: Quality Unit > Reviews and Approvals > Change control > Documentation.

After Redica Systems completes building our labeling models for Health Canada Inspection Report Cards, we will have the ability to perform a more in-depth analysis of the inspection observations in those documents. For now, an understanding of where ROEB inspectors are finding deficiencies is instructional.

For an in-depth analysis of the 22 years of FDA 483 documents by quality system and subsystems, click here.

Conclusion

As shown by both the respective inspection processes and results, Health Canada and FDA are similar in some ways and unique in others. Their inspection results are unique enough that apples-to-apples comparisons are not possible. The takeaway for global leaders in pharmaceutical Quality and Regulatory roles is that both must be independently interpreted and monitored. However, when evaluating the relative compliance risk of a specific site, looking at the inspection results for that site from both Health Canada and FDA will paint the most complete picture.