Drugs

Les Importations Herbasanté CGMP Issues

An 8/14-8/18/2023 FDA inspection at the Les Importations Herbasanté drug manufacturing facility in Saint-Laurent, Canada, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/31 Warning Letter says the specific violations were:

failing to appropriately sample, test, or examine the components, containers, or closures released for use in the manufacture of a drug product and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failure of the quality control unit to exercise its responsibility to ensure that drug products that are manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter notes that FDA cited similar violations in previous inspections. “You proposed specific remediation for these findings in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA says the firm is responsible for the quality of the drugs it produces as a contract facility regardless of agreements in place with product owners. It recommends the firm retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed Les Importations on an import alert on 1/26.

The company was told to correct violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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