In response to a question at the hearing regarding the number of inspections that were performed in 2020, 2021 and the first three months of 2022, and the number of suspensions that may have resulted from them, Health Canada provided the following information in a letter to the Committee:

2020

No inspections were conducted in 2020 as the pilot had not yet launched. However, as part of Compliance Monitoring Projects in 2019-2020, site visits were conducted at five companies previously visited in 2017 to verify compliance and follow-up on implementation of corrective actions related to specific GMP requirements of the Natural Health Products Regulations. Of these companies, one had its license suspended due to regulatory deficiencies—related to finished product specifications, operations, personnel, quality assurance and product stability—that persisted after the company was notified of these issues. The company provided additional information, which after review allowed the licences to be reinstated.

2021-2022

Inspections Conducted

In 2021, as part of our continued proactive and risk-based approach, and to complement our paper-based licensing process and complaint-based compliance verification process, we developed and implemented the pilot NHP GMP Inspection Program.

As part of the pilot, inspectors conducted inspections of 27 companies (18 importers and 9 manufacturers) in 2021, and 9 more inspections at manufacturers from January to March 2022. This represents about 4% of all companies with active NHP site licences in Canada.

Findings

To date, the results of 33 of the 36 inspections are identified. The most common regulatory deficiencies were related to quality assurance, product stability, and finished product specifications. Inspectors identified serious regulatory deficiencies at 13 of the 33 companies with completed inspections, which led to compliance and enforcement actions being taken with their site and/or product licence(s).

Compliance & Enforcement Actions taken:

• 7 companies received a notice of an intent to suspend their site licence and product licence(s).
• 4 companies received a notice of an intent to suspend their site licence.
• 2 companies received a notice of immediate suspension of their site licence and notice of intent to suspend their product licences.

Corrective Actions

• In six of the 13 cases where compliance action was taken, the companies proposed adequate corrective actions for the identified regulatory deficiencies, which allowed for closure of the intent to suspend and/or re-instatement of licence(s).
• In one case, the company’s proposed corrective actions were not adequate, which led to suspension and then cancellation of their product licences. Further action was not taken on their site licence as they allowed their site licence to expire while addressing the deficiencies noted at the time of inspection.
• In another case, the proposed corrective actions are currently under review by the inspector.
• In the remaining five cases, the corrective actions are pending from the companies.